California Bill Would Let Children Get COVID-19 Jab Without Parental Approval

 by Allen Zhong via The Epoch Times,

California Democrat lawmakers introduced a bill that would allow children to be administered with COVID-19 vaccines without parental consent.

Senate Bill 866, also known as the Teens Choose Vaccines Act, has been introduced by state Senators Scott Wiener and Richard Pan, who intended to add a new section to the California Family Code.

“A minor 12 years of age or older may consent to a vaccine that is approved by the United States Food and Drug Administration and meets the recommendations of the Advisory Committee on Immunization Practices (ACIP) of the federal Centers for Disease Control and Prevention (ACIP) without the consent of the parent or guardian of the minor,” read the proposal.

The bill doesn’t mention COVID-19, the disease caused by the CCP (Chinese Communist Party) virus, but refers to human papillomavirus (HPV) and hepatitis B vaccines instead.

However, Wiener said COVID-19 vaccination for children is an apparent goal of the bill.

“With the persistence of the COVID-19 pandemic and the widespread availability of highly effective and safe vaccines to treat serious COVID-19 illness, it’s more important than ever that young adults be able to access vaccines,” he said in a statement.

Current California law requires parental consent for children ages 12 to 17 to be vaccinated unless the vaccine specifically targets a sexually transmitted disease.

Besides Wiener and Pan, the bill has eight coauthors, including seven assembly members and one senator.

It’s unclear how widely the bill was received in the state legislature, controlled by the Democratic Party in both the upper and lower house in The Golden State.

California Assembly Speaker Anthony Rendon refused to comment on the bill, saying the bill hasn’t yet reached the Assembly floor.

The Epoch Times reached out to California Senate Majority Leader Robert Hertzberg for comment.

The Centers for Disease Control and Prevention (CDC) recommends everyone ages 5 years and older get a COVID-19 vaccine, saying vaccines are safe for children and teens.

The agency also recommended children 12 years and older get a Pfizer-BioNTech booster.

However, some prominent epidemiologists have reservations about vaccinating children.

Dr. Peter McCullough, a leading cardiologist and epidemiologist, said that healthy children should not be given the COVID-19 vaccine because the percentage of those children that die from the virus is minuscule, but the adverse effects from the vaccines in that age group are of great concern.

Dr. Robert Malone, a virologist and immunologist who has contributed significantly to the technology of mRNA vaccines, shares the same viewpoint.

“There’s a good chance that if your child takes the vaccine, they won’t be damaged, they won’t show clinical symptoms—[but] they may have subclinical damage,” Malone told EpochTV’s “American Thought Leaders” program in an interview. “But the question is, do you want to take that chance with your child? Because if you draw the short straw and your child was damaged, most of these things, if not all of them, are irreversible. There is no way to fix it.”

https://www.zerohedge.com/political/california-bill-would-let-children-get-covid-19-jab-without-parental-approval

Fast, cheap test can detect COVID-19 virus’ genome without need for PCR

 Researchers at the University of Washington have developed a new test for COVID-19 that combines the speed of over-the-counter antigen tests with the accuracy of PCR tests that are processed in medical labs and hospitals.

The Harmony COVID-19 test is a diagnostic test that, like PCR tests for COVID-19, detects genetic material from the SARS-CoV-2 virus. But whereas conventional PCR tests can take several hours, the Harmony kit can provide results in less than 20 minutes for some samples and with similar accuracy.

"We designed the test to be low-cost and simple enough that it could be used anywhere," said Barry Lutz, a UW associate professor of bioengineering and investigator with the Brotman Baty Institute for Precision Medicine. "We hope that the low cost will make high-performance testing more accessible locally and around the world."

Lutz is senior author on a paper published Dec. 15 in Science Advances that describes the Harmony COVID-19 test kit. The researchers developed Harmony to be simple and easy-to-use, employing ready-to-use reagents. The test uses a "PCR-like" method to detect the presence of the SARS-CoV-2 RNA genome in a nasal swab sample with the aid of a small, low-cost detector, which was also designed by Lutz's group. A smartphone is used to operate the detector and read the results. The detector can handle up to four samples at a time and would fit into a standard car's glove compartment.

The accuracy of COVID-19 tests has been a pressing matter throughout the pandemic. Many at-home antigen kits for COVID-19, which detect pieces of the proteins the virus creates instead of its genetic material, are 80-85% accurate, though accuracy may drop with the omicron variant, which harbors a relatively high number of mutations not found in other strains. PCR tests are generally 95% accurate or better -- a key FDA benchmark -- but require expensive equipment and a long wait for results.

Initial results reported in the paper show that the Harmony kit is 97% accurate for nasal swabs. The Harmony kit detects three different regions of the virus' genome. If a new variant has many mutations in one region, the new test can still detect the other two. It can, for example, detect the omicron variant, which has dozens of mutations in the region of the genome that encodes the so-called spike protein.

Though tests based on PCR -- or polymerase chain reaction -- are highly accurate, a key limitation is that PCR tests require dozens of cycles of heating and cooling to detect genetic material in a sample. The test developed by the UW team sidesteps this issue by relying on a PCR-like method known as RT-LAMP, which doesn't have the same stringent temperature-cycling requirements.

"This test operates at a constant temperature, so it eliminates the time to heat and cool and gives results in about 30 minutes," said Lutz.

Lutz and two colleagues spun out a new company from the UW, Anavasi Diagnostics, which last year was supported by $300,000 from WE-REACH and later received $14.9 million in grants from the National Institutes of Health to develop the Harmony prototype kit into a product and scale up manufacturing to help address the ongoing shortage of COVID-19 diagnostic tests.

Initially, Lutz and his team hope the kits could be made available first for use in clinics, as well as other settings with medical oversight, such as workplaces and schools. Later, they would like to adapt the test for home use.

"For a long time, the options have been either a PCR test that is expensive and typically takes a day or more to get a result, or a rapid antigen test that gives fast results and is low cost, but typically has lower accuracy than a lab PCR test," said Lutz. "From the first day, we designed our test to be manufacturable at low cost and high volume, while delivering fast results with PCR-like performance."

The NIH funding will support high-volume manufacturing at a new Anavasi facility near Seattle.

"We plan to make our test accessible and affordable throughout the world," said Lutz.

Lead author on the paper is Nuttada Panpradist, a recent UW doctoral alum in bioengineering. Second author is Enos Kline, a UW research scientist in bioengineering, who initiated the project in early 2020. Co-authors in the Department of Bioengineering are doctoral students Robert Atkinson, Ian Hull, Qin Wang, and Shane Gilligan-Steinberg; research scientists Michael Roller, Jack Henry Kotnik, Crissa Bennett and Daniel Leon; and doctoral alum Amy Oreskovic. Other co-authors, all at the UW, are Victoria Lyon in the Department of Family Medicine; Matthew Thompson, a professor of global health and the Helen D. Cohen Endowed Professor in Family Medicine; Peter Han in the Department of Genome Sciences; Lea Starita, an assistant professor of genome sciences; and Paul Drain, an associate professor of global health, of medicine and of epidemiology. The research was funded by the Seattle Flu Study and the National Institutes of Health.

---

Story Source:

Materials provided by University of Washington. Original written by James Urton. Note: Content may be edited for style and length.

---

Journal Reference:

1. Nuttada Panpradist, Enos C. Kline, Robert G. Atkinson, Michael Roller, Qin Wang, Ian T. Hull, Jack H. Kotnik, Amy K. Oreskovic, Crissa Bennett, Daniel Leon, Victoria Lyon, Shane D. Gilligan-Steinberg, Peter D. Han, Paul K. Drain, Lea M. Starita, Matthew J. Thompson, Barry R. Lutz. Harmony COVID-19: A ready-to-use kit, low-cost detector, and smartphone app for point-of-care SARS-CoV-2 RNA detection. Science Advances, 2021; 7 (51) DOI: 10.1126/sciadv.abj1281

https://www.sciencedaily.com/releases/2022/01/220124194941.htm

Current vaccines teach T cells to fight Omicron

 Scientists at La Jolla Institute for Immunology (LJI) have found that four COVID-19 vaccines (Pfizer-BioNTech, Moderna, J&J/Janssen, and Novavax) prompt the body to make effective, long-lasting T cells against SARS-CoV-2. These T cells can recognize SARS-CoV-2 Variants of Concern, including Delta and Omicron.

"The vast majority of T cell responses are still effective against Omicron," says LJI Professor and study co-leader Alessandro Sette, Dr. Biol.Sci.

"These cells won't stop you from getting infected, but in many cases they are likely to keep you from getting very ill," adds LJI Professor Shane Crotty, Ph.D.

"And this is true in all the type of vaccines we studied -- and up to six months after vaccination," says LJI Instructor Alba Grifoni, Ph.D., who co-led the work with Sette and Crotty.

These data come from adults who were fully vaccinated, but not yet boosted. The researchers are now investigating T cell responses in boosted individuals and people who have experienced "breakthrough" COVID-19 cases.

The new Cell study also shows that fully vaccinated people have fewer memory B cells and neutralizing antibodies against the Omicron variant. This finding is in line with initial reports of waning immunity from laboratories around the world.

Without enough neutralizing antibodies, Omicron is more likely to cause a breakthrough infection. Fewer memory B cells means the body will then be slower to churn out additional neutralizing antibodies to fight the virus.

"Most of the neutralizing antibodies, i.e., the antibodies that work well against SARS-CoV-2, bind to a region called the receptor binding domain, or RBD," says LJI Instructor Camila Coelho, Ph.D., who served as co-first author of the study. "Our study revealed that the 15 mutations present in Omicron RBD can considerably reduce the binding capacity of memory B cells, compared to other SARS-CoV-2 variants such as Alpha, Beta and Delta."

How T cells fight Omicron

The good news is that neutralizing antibodies and memory B cells are just two arms of the body's adaptive immune response. In a person exposed to SARS-CoV-2, T cells do not prevent infection. Instead, T cells patrol the body and destroy cells that are already infected, which prevents a virus from multiplying and causing severe disease.

The LJI team believes the "second line of defense" from T cells helps explain why Omicron infections are less likely to lead to severe disease in fully vaccinated people. (The variant is also appears to infect different tissues)

To know whether the vaccine-induced T cells they detected in their study were actually effective against variants such as Delta and Omicron, the scientists took a close look at how the T cells responded to different viral "epitopes."

Every virus is made up of proteins that form a certain shape or architecture. A viral epitope is a specific landmark on this architecture that T cells have been trained to recognize. The current COVID-19 vaccines were designed to teach the immune system to recognize specific epitopes on the initial "Alpha" variant of SARS-CoV-2. As the virus has mutated, its architecture has changed, and the concern is that immune cells will no longer recognize their targets.

The new study shows that while the architecture of Omicron is different enough to evade some neutralizing antibodies and memory B cells, memory T cells still do a good job of recognizing their targets, even on the highly mutated Omicron variant. Overall, at least 83 percent of the CD4+ (helper) T cell responses and 85 percent of the CD8+ T cell responses stayed the same, no matter the vaccine or the variant.

Crotty notes that the memory B cells that do bind Omicron are likely to also contribute to protection against severe disease. "Vaccinated people have memory CD4+ T cells, CD8+ T cells, and memory B cells to help fight the infection if the virus gets past the initial antibodies, and having multiple lines of defense is likely an important strength," Crotty says.

Omicron is still a threat

The researchers emphasize that no one should count on T cell protection alone. The LJI study sheds light on immunity at the population level, but individual immune responses vary, and relying on one's untested immune system to fight COVID is a roll of the dice.

"I'd urge people to still be cautious and keep wearing masks," says Alison Tarke, a graduate student and member of the Sette Lab who served as co-first author with Coelho. "There is a chance you are one of the few people with a declining immune response."

"This work also emphasizes the importance of getting a booster," adds Sette. (Find a booster near you)

The Sette and Crotty Labs have teamed up on COVID-19 research since early 2020. With the Sette Lab's expertise in T cells and the Crotty Lab's expertise in vaccine design and B cell responses, the collaboration has led to key insights into pre-existing SARS-CoV-2 immunity, vaccine responses, severe COVID cases and more.

Grifoni says the researchers are now looking at two pressing questions. First, they'd like to see what T cells, B cells and antibody responses look like after COVID-19 booster shots. Second, they are investigating what the immune response looks like after a breakthrough infection. (Volunteer for an LJI Clinical Study)

Additional authors of the study, "SARS-CoV-2 vaccination induces immunological memory able to cross-recognize variants from Alpha to Omicron," are co-first author Zeli Zhang, co-first author Jennifer M. Dan, Esther Dawen Yu, Nils Methot, Nathaniel I. Bloom, Benjamin Goodwin, Elizabeth Phillips, Simon Mallal, John Sidney, Gilberto Filaci, Daniela Weiskopf and Ricardo da Silva Antunes.

This research was supported by the National Institutes of Health's National Institute of Allergy and Infectious Diseases (contracts No. 75N93021C00016 to A.S. and 75N9301900065) and a PhD student fellowship through the Clinical and Experimental Immunology Course at the University of Genoa, Italy.

---

Story Source:

Materials provided by La Jolla Institute for Immunology. Original written by Madeline McCurry-Schmidt. Note: Content may be edited for style and length.

---

Journal Reference:

1. Alison Tarke, Camila H. Coelho, Zeli Zhang, Jennifer M. Dan, Esther Dawen Yu, Nils Methot, Nathaniel I. Bloom, Benjamin Goodwin, Elizabeth Phillips, Simon Mallal, John Sidney, Gilberto Filaci, Daniela Weiskopf, Ricardo da Silva Antunes, Shane Crotty, Alba Grifoni, Alessandro Sette. SARS-CoV-2 vaccination induces immunological T cell memory able to cross-recognize variants from Alpha to Omicron. Cell, 2022; DOI: 10.1016/j.cell.2022.01.015

https://www.sciencedaily.com/releases/2022/01/220124151101.htm

The Alzheimer’s Death Panel

 President Biden says he wants to increase access to health care. But that’s hard to square with the unprecedented proposal from the Centers for Medicare and Medicaid Services this month to restrict Medicare payment for a class of new treatments for Alzheimer’s disease.

CMS recommendation follows controversy over Biogen’s Food and Drug Administration approval last summer in its treatment of Alzheimer’s disease Aduhelm. The monoclonal antibody eliminates amyloid plaque in the brain, a hallmark of the disease. It is the first treatment shown in clinical trials to slow the progression of Alzheimer’s disease.

A randomized controlled trial showed that a high dose of the treatment eliminated 71% of plaque buildup after 18 months and significantly slowed disease progression, as assessed by caregivers and doctors. Another trial also showed amyloid clearance but failed to demonstrate a significant impact on disease progression.

Biogen erred in stopping the two trials earlier. But he then worked with the FDA on a post-hoc review to figure out the discordant results. A major discrepancy: the patients of the second received less treatment. The longer patients in both trials received a high dose of the drug, the less they deteriorated.

Aduhelm’s critics, largely from the public health left, say the successful trial was likely a false positive since other experimental monoclonal antibodies showed no effect on amyloid or progression. of the disease. Some neurologists also believe that removing amyloid is ineffective because Alzheimer’s disease has other causes.

No one disputes that many factors likely contribute to Alzheimer’s disease. But Aduhelm is the first drug to show a significant effect on disease progression in early-stage patients. It has the potential to extend the time patients can live independently and spend with loved ones, while researchers work on other therapies that target different disease pathways.

Critics have urged the FDA to require another large trial before granting approval. It would take several years. The FDA instead granted expedited approval to Aduhelm, which Congress has authorized to give patients faster access to promising drugs that treat serious conditions and address an unmet medical need when there is uncertainty about their advantages.

After losing to the FDA, Aduhelm’s critics lobbied CMS to restrict Medicare coverage. CMS has almost always covered FDA-approved drugs. But now it says Medicare will only pay for Aduhelm and any future FDA-approved monoclonal targeting Alzheimer’s amyloid if patients enroll in a randomized controlled trial. CMS reverses the decision of the FDA and the doctors who want to prescribe the drugs.

Three more amyloid-targeting monoclonals by Eli Lilly, Roche and a Biogen-Eisai partnership showed positive results in early trials, some stronger than Aduhelm. Drugmakers could get fast-track FDA approval within the next two years after they finish compiling clinical trial data. But it doesn’t matter how effective these treatments are in clinical trials.

Under CMS’s proposal, Medicare will only pay them if patients enroll in duplicate trials in which they could be assigned a placebo instead of the drug. Yet patients with Alzheimer’s disease will only be able to enroll in these trials if they live near major health care centers with the resources to conduct them. Bad luck for the seniors of Fargo.

CMS also states that “the diversity of patients included in each trial should be representative of the national population diagnosed with Alzheimer’s disease.” It’s a salute to liberal criticism that Aduhelm’s trials included too few black people, who are twice as likely to develop dementia as white people. Yet restricting CMS coverage will disproportionately harm black patients.

There is vigorous scientific debate about the role of amyloid in Alzheimer’s disease and the causes of the disease. According to CMS, this is irrelevant because it indicates that the biggest contributor to cognitive decline is cerebrovascular disease, including stroke. “The implication is that any treatment specifically targeting amyloid may be less effective the higher the level of mixed disease in a given patient,” says CMS. But CMS could use that same reasoning to restrict any future Alzheimer’s treatments, not just those that target amyloid.

***

CMS, which reports to the secretary of HHS, has yet to make a final payment decision. A better option is for CMS to require healthcare providers to collect real-world efficacy and safety data for Aduhelm. But that wouldn’t achieve the left’s goal of limiting expensive treatment for seniors. Liberals warn Medicare spending will skyrocket if seniors have access to Aduhelm, which costs $28,200 a year.

This is the real reason the Biden administration wants to preemptively restrict Medicare coverage of all amyloid-targeting monoclonals. Progressives want to expand Medicare benefits to win the votes of seniors, then ration treatments to contain government spending. Drugs for Alzheimer’s disease will not be the last target of rationing.

https://newsnetdaily.com/the-alzheimers-death-panel-wsj-top-stories/

Why Medicare Doesn’t Pay for Rapid At-Home Covid Tests

 What group is especially vulnerable to the ravages of covid-19 even if fully vaccinated and boosted? Seniors. And who will have an especially tough time getting free at-home covid tests under the Biden administration’s plan? Yes, seniors.

As of Jan. 15, private insurers will cover the cost of eight at-home rapid covid tests each month for their members — for as long as the public health emergency lasts.

Finding the tests will be hard enough, but Medicare beneficiaries face an even bigger hurdle: The administration’s new rule doesn’t apply to them.

It turns out that the laws governing traditional Medicare don’t provide for coverage of self-administered diagnostic tests, which is precisely what the rapid antigen tests are and why they are an important tool for containing the pandemic.

“While at this time original Medicare cannot pay for at-home tests, testing remains a critical tool to help mitigate the spread of covid,” a statement from the federal Centers for Medicare & Medicaid Services said. Medicaid and CHIP cover at-home covid tests, with no cost to beneficiaries, based on a 2021 Biden administration mandate.

Medicare patients are left to seek free tests other ways, including through the administration’s new website, covidtests.gov, and at community centers. The Medicare program does cover rapid antigen or PCR testing done by a lab without charging beneficiaries, but there’s a hitch: It’s limited to one test per year unless someone has a doctor’s order.

More needs to be done, advocates say.

The administration has changed some Medicare rules during the pandemic, including improving access to telehealth services and nursing home care, said David Lipschutz, associate director and senior policy attorney at the Center for Medicare Advocacy.

“We know that the Medicare program has significant flexibility relative to the public health emergency, and it has demonstrated it has the ability to alter the rules,” Lipschutz said. “We think they should find the flexibility to offer the covid at-home tests for free.”

Q: Why can’t the Medicare program reimburse beneficiaries for the over-the-counter tests or pick up the tab at the pharmacy as commercial health plans will do?

The services the Medicare program pays for are spelled out in federal law.

“It generally excludes over-the-counter things,” said Casey Schwarz, senior counsel for education and federal policy at the Medicare Rights Center, an advocacy group. 

The public health emergency was recently extended 90 days, through mid-April, and the administration could yet decide to expand coverage. Some lawmakers in Congress are urging the administration to cover the tests.

“Demanding Medicare recipients — nearly one-fifth the population of the United States — to foot the bill out-of-pocket for at-home tests is unfair, inefficient, and will cost lives,” said Rep. Bill Pascrell Jr. (D-N.Y.), who has urged the Biden administration to expand Medicare coverage to include them.

It may not be a simple change, as these tests appear to fall into coverage gaps. Medicare Part A covers hospitalization, and Part B generally covers provider-based services like doctor visits and lab tests. Part D covers drugs.

“So there’s a little bit of a question of where this type of benefit would fit,” Schwarz said.

People in private plans sometimes pay upfront for services and then are reimbursed by their health plan. But that’s not how Medicare works. The program pays providers, not beneficiaries. So that’s another wrinkle that would have to be ironed out.

Q: So how can a Medicare beneficiary get free at-home covid tests?

There are a couple of options. This week, the Biden administration launched a website, covidtests.gov, where anyone, including Medicare beneficiaries, can order free at-home covid tests. One billion tests eventually will be available. Each residence initially can receive four tests.

Four tests is a far cry from the eight monthly tests that people with private insurance can be reimbursed for. But it’s better than nothing, experts say, especially when preventing the spread of covid requires repeated testing over a period of days.

“Four tests is not a lot of tests,” said Juliette Cubanski, deputy director of the program on Medicare policy at KFF. “This is one of the most at-risk populations, and to not have the opportunity to buy at-home tests and get reimbursed puts this whole population on their back foot.”

The Biden administration is also providing up to 50 million additional free at-home tests to community health centers and Medicare-certified health clinics.

But 50 million tests won’t even provide one test apiece to the 62 million Medicare beneficiaries, Lipschutz said.

About 4 in 10 Medicare beneficiaries are in Medicare Advantage managed-care plans. These private plans may offer free at-home tests to members, but it’s not required. Enrollees should check with their plans to see whether that’s an option.

Q: What other free covid testing options are available to Medicare beneficiaries?

In traditional Medicare, beneficiaries can get rapid antigen or PCR diagnostic tests without paying anything out-of-pocket if the test is ordered by a doctor or other health care provider and performed by a lab.

The federal government has set up more than 10,000 free pharmacy testing sites across the country that Medicare beneficiaries can visit as well.

With the recent extension of the public health emergency, the situation is fluid, and Medicare beneficiaries may yet get coverage for at-home covid tests that’s comparable to what privately insured people now have.

“This is all a moving target,” Lipschutz said.

https://khn.org/news/article/why-medicare-doesnt-pay-for-rapid-at-home-covid-tests/

Oncopeptides Withdraws Withdrawal of First Marketed Drug

 Swedish pharmaceutical company Oncopeptides announced that it has contacted the U.S Food and Drug Administration and rescinded an October 22^nd, 2021 letter requesting voluntary withdrawal of the NDA of  Pepaxto® (INN melphalan flufenamide) in the United States.

Oncopeptides has discontinued the marketing of Pepaxto, also called melflufen, in the U.S and does not intend to market Pepaxto in the U.S. at this time. 

Further review and analyses of the heterogenous Overall Survival data from the phase III OCEAN study and other relevant trials have led the company to reconsider its previous voluntary withdrawal request. Oncopeptides gave no further details about its decision.  However, the company has initiated a dialogue with the FDA to review the new data.

Based in Stockholm, Sweden, Oncopeptides is focused on the research and development of therapies for difficult-to-treat hematological diseases. The company uses its proprietary peptide-drug conjugate (PDC) platform to develop compounds that rapidly and selectively deliver cytotoxic agents into cancer cells. 

Pepaxto, the first drug coming from the PDC platform, was granted accelerated approval in the U.S. in February 2021, in combination with dexamethasone, for treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent and one CD38-directed monoclonal antibody.  Oncopeptides is developing several new compounds based on the PDC platform.

Oncopeptides voluntarily stopped marketing the drug in the U.S. on October 22^nd, 2021, following the phase III OCEAN study, which showed an overall survival in the intent-to-treat population with a HR of 1.104.  The study was a post-approval requirement under the accelerated approval program.

In an October news release, the company stated that during dialogue with the FDA, “it has become evident that the FDA does not consider that the phase III OCEAN study meets the criteria of a confirmatory study. Oncopeptides believes that the OCEAN data are scientifically meaningful and that the findings warrant further evaluation.”

Marty J Duvall, chief executive officer at Oncopeptides, stated that the move ‘to withdraw Pepaxto from the market has been a difficult decision, that has been made with great consideration and with the best intentions for patients and shareholders. He added that the company would refocus its resources and energy on R&D, remaining true to its mission of bringing hope to patients through science.

On January 13^th, the results of the phase III OCEAN study were published in the Lancet Haematology. The study was a head-to-head comparison of Pepaxto plus dexamethasone versus pomalidomide plus dexamethason.  In the intent-to-treat population, melflufen met the primary endpoint of superior Progression-Free Survival (PFS), with a median PFS of 6.8 months. This was compared to 4.9 months for pomalidomide.

https://www.biospace.com/article/oncopeptides-withdraws-withdrawal-of-first-marketed-drug-/

Merck Remains Committed to Chronic Cough Drug Following FDA Rejection

 The U.S. Food and Drug Administration issued a Complete Response Letter to Merck & Co. for its New Drug Application for gefapixant for refractory chronic cough or unexplained chronic cough. The drug is a non-narcotic, oral selective P2X3 receptor antagonist.

The rejection was not related to the safety of the drug, although Merck did not specify details from the CRL. The company said it was reviewing the letter and planned to meet with the FDA to discuss the next steps.

“We remain committed to advancing gefapixant for patients with refractory or unexplained chronic cough and will work with the FDA to address the agency’s feedback,” said Dr. Roy Baynes, senior vice president and head of Global Clinical Development, chief medical officer, Merck Research Laboratories. “We believe there is a significant unmet need to help patients manage their chronic cough, as there are no available treatment options indicated in the U.S. specifically for this condition.”

However, last week, the drug was approved in Japan under the brand name Lyfnua.

The FDA initially accepted the NDA on March 1, 2021. The NDA was built on data from the COUGH-1 and -2 studies, the first companion Phase III trials conducted in patients with RCC. A total of 2,044 patients were treated in the trials. Participants were randomly chosen to receive either 45 mg twice a day of gefapixant, 15 mg twice a day, or placebo. The primary efficacy measures were 24-hour cough frequency at week 12, and 24-hour cough frequency at week 24 for COUGH-1 and COUGH-2, respectively. The cough frequency was measured using an ambulatory digital audio recording device.

The secondary endpoints in both studies included awake coughs per hour and the percentage of patients with more than a 1.3-point increase from baseline in the Leicester Cough Questionnaire (LCQ) total score. There was a 12-week treatment period for COUGH-1 and a 40-week extension period. COUGH-2 had a 24-week treatment period and a 28-week extension period.

“COUGH-1 and COUGH-2 are the first companion Phase III trials in refractory or unexplained chronic cough, underscoring Merck’s commitment to fully researching the potential for gefapixant in this patient population,” Baynes said in a September 8, 2020, statement. “Both trials met the primary endpoint at the 45 mg twice daily dosage, significantly reducing cough frequency in these patients, and we are grateful for the opportunity to share these data with the scientific community.”

According to estimates, between 5% and 10% of adults worldwide suffer from chronic cough. A subset has a refractory or unexplained chronic cough and seems more sensitive to triggers that otherwise healthy people don’t have.

“These include everyday things such as talking, laughing, a change in air temperature or exposure to aerosols or food odors, and to date treatment options are extremely limited for these patients,” said Dr. Lorcan McGarvey, clinical professor, Wellcome-Wolfson Institute of Experimental Medicine, School of Medicine, Dentistry and Biomedical Sciences, Queen’s University Belfast. “Given the significant unmet need for these patients, we are strongly encouraged by the findings of COUGH-1 and COUGH-2 and the potential for a new therapeutic option for patients who are struggling with the burden of this disease, often for many years without relief.”

https://www.biospace.com/article/fda-rejects-merck-s-cough-drug-gefapixant/