AstraZeneca announced top-line results from Terranova, the second of two pivotal Phase III trials for Fasenra in patients with moderate to very severe chronic obstructive pulmonary disease. The trial did not meet the primary endpoint of a statistically-significant reduction of exacerbations. This news follows the announcement earlier this month that the first pivotal Phase III trial, Galathea, did not meet its primary endpoint, AstraZeneca pointed out. “The safety and tolerability findings in Terranova were consistent with those observed in previous trials with Fasenra. A full evaluation of the data is ongoing, and the results will be submitted for presentation at a forthcoming medical meeting. The Company does not currently intend to make a regulatory submission,” it added.
Wednesday, May 30, 2018
Novartis to get FDA priority review for aplastic anemia med
Novartis announced that the FDA has accepted the company’s supplemental New Drug Application, or sNDA, and granted Priority Review designation to Promacta in combination with standard immunosuppressive therapy, or IST, for first-line treatment of severe aplastic anemia, or SAA.
TherapeuticsMD gets FDA OK for estrogen product
TherapeuticsMD, Inc. (NASDAQ: TXMD) today announced that the United States Food and Drug Administration (FDA) has approved IMVEXXY (estradiol vaginal inserts) for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. IMVEXXY is the only product in its therapeutic class to offer a 4 mcg and 10 mcg dose, the 4 mcg representing the lowest approved dose of vaginal estradiol available.
“IMVEXXY is a bio-identical vaginal estrogen product that offers a fraction of the estrogen contained in the average doses of many existing products currently on the market,” said Brian Bernick, MD, Chief Clinical Officer of TherapeuticsMD. “IMVEXXY is the only product specifically designed to be applicator-free. It dissolves completely without mess or additional clean-up, and can be used anytime of day. It allows women the freedom to immediately return to their normal daily activities. Studies showed that, in patients who used IMVEXXY, systemic absorption of estradiol remained within postmenopausal range.”
“We are excited to bring IMVEXXY to market as TherapeuticsMD’s first FDA-approved drug as we strive to be the premier Women’s Health Company,” said Robert Finizio, Chief Executive Officer of TherapeuticsMD. “IMVEXXY reflects our long-standing corporate mission and commitment to health solutions that women want, based on the concepts of medical need, efficacy, safety, simplicity, and affordability. IMVEXXY will be offered at a price in parity with other products that have been on the market for 10 to 30 years. By ensuring patients can access IMVEXXY at an affordable price, TherapeuticsMD is doing the right thing for women.”
Tuesday, May 29, 2018
Reset your routers to avoid malware attack, FBI warns
Russian hackers may be coming for you, and there’s one way to stop them: Turn off your Wi-Fi.
The Federal Bureau of Investigation said Friday anyone with a small office or home router should reboot it to stop the spread of malware. A potential attack had infected hundreds of thousands devices across 54 countries with software called VPNFilter, which was traced back to Ukraine where it was first found in 2016, it said.
The software had not had any negative effects yet, but would allow devices to be hacked for a number of nefarious purposes. Ukranian officials said in a statement they suspect Russia is behind the attack.
To thwart it, the FBI has instructed Americans to do what many IT professionals ask you to do when you have a problem with your Wi-Fi: Turn off your router and then turn it back on again.
“The FBI recommends any owner of small office and home office routers reboot the devices to temporarily disrupt the malware and aid the potential identification of infected devices,” it said in a statement.
While the hack does not affect all routers, experts suggest everyone upgrade their home and office internet security, install the latest firmware and change the default password, said Chester Wisniewski, principal research scientist at security firm Sophos.
The FBI said last week it had seized the domain used to issue instructions to the infected devices. When users reset their machines, the traffic will reroute through the bureau’s site to clean them up.
This particular kind of vulnerability is alarming because it can be used for a number of attacks, said Caleb Barlow, vice president of threat intelligence at IBM IBM, -1.68%It allows the machine to install additional software or internally change devices rendering them unusable.
“Think of it like a garage door — once you have access to it, you can drive anything from a bicycle to a bus into it,” he said. “It is up to the adversary to decide what to park in that garage.”
The hack underscores ongoing issues with the security of routers, which rarely automatically update with patches for vulnerabilities. Experts suggest not using routers issued by your internet service provider and instead buying more expensive, and more secure devices.
“This should be the default moving forward,” said David Ginsburg, vice president at Cavirin, a Santa Clara, Calif.-based provider of cybersecurity. “We’re used to this with our smartphones and laptops, and think nothing of updates.”
CMS giving big, erroneous plug to Medicare Advantage in handbook draft?
- CMS’ 2019 Medicare & You handbook appears to give Medicare Advantage an extra plug, judging by changes in a draft version of next year’s manual, Axios reports.
- Compared with this year’s handbook, the draft replaces a section on “quality of care” with one on “coverage and cost determinations” — suggesting that cost-conscious beneficiaries might want to shop for MA plans.
- The revised version also devotes a page to promoting Medicare Advantage open enrollment, a provision in the 21st Century Cures Act that allows people to try out a plan for three months before committing to it.
Also, the draft adds a section explaining that people in MA plans “have the right to request a preauthorization” for healthcare services or equipment, encouraging people to use this tactic when choosing providers.
That may win kudos from insurers, which have been flocking to the MA market, but pointing out such policies as a way to get people to shop around is likely to get pushback from providers.
The draft handbook also includes what could be misleading information on private contracting, which lets Medicare patients and providers who opt out of Medicare sign private contracts for services. A new sentence reads: “Private contracts give you and your provider the flexibility to set up your own payment terms that work best for you.” What is left out is that people who sign private contracts could face higher fees or surprise billing.
In a letter to CMS Administrator Seema Verma, three consumer groups — the Center for Medicare Advocacy, Justice in Aging and the Medicare Rights Center — criticized the draft, saying suggestions that Medicare Advantage is the less expensive alternative for beneficiaries are overstated and the draft doesn’t clarify the difference between traditional Medicare and Medicare Advantage.
“Even more problematic is the treatment of prior authorization in Medicare Advantage,” the groups write. The draft “attempts to paint this restriction on access to services as a benefit, rather than what it is, a mandatory hurdle for Medicare Advantage members that is not required for individuals in Original Medicare.”
Payers like MA, which they see as a stable market. The average premium for MA plans was expected to be about 6% lower this year than last year, and CMS predicted 77% of MA enrollees would stay in their current plan. The typical enrollee is someone who once had employer-based healthcare, so is mostly familiar with insurance policies and isn’t likely to have untended healthcare needs.
Providence St. Joseph rolls out new end-of-life initiatives
Dr. Ira Byock would make weeklong trips to his hometown in New Jersey to drive his dad to radiation therapy as he battled pancreatic cancer.
The daily 2½-hour ritual would stir up memories as Byock and his dad took the side roads through familiar neighborhoods. His father would talk about selling the family business, a small cigarette wholesale and vending business built from scratch. He shared what it was like to be dying, striking a similar tone to when he taught Byock the difference between right and wrong decades earlier.
During one appointment, Byock’s dad rested his eyes as they waited in the cancer center, and said, “They give you only six months to live, and then, little by little, they take it back from you.”
These conversations are at the core of Providence St. Joseph’s new end-of-life initiatives.
“We are trying to create a new environment where it’s easier to ask these questions, listen better and document all this in the electronic health record so it’s part of the routine,” said Byock, who is the founder and chief medical officer of Providence St. Joseph Health’s Institute for Human Caring.
The Renton, Wash.-based health system is offering a new advanced directive online toolkit—available in multiple languages and tailored for each of the seven states where the health system operates—that helps patients choose what type of end-of-life care they want, accessible through Providence St. Joseph’s electronic health record. The EHR will alert doctors if treatments contradict a patient’s requests and refer patients to goals-of-care plans and advance directives.
The organization is training its physicians and staff across its 51-hospital network to help them broach these end-of-life conversations and clarify realistic outcomes prior to potentially burdensome treatments.
Providence St. Joseph also sends patients and families videos and other resources to help them understand their medical conditions and options for care near the end of life. Its Institute for Human Caring also created a storytelling project called Hear Me Now, in partnership with StoryCorps, which offers patients, family members and professional caregivers a platform to share personal stories related to “whole-person care.”
“For some clinicians, it’s easier to say we will just do more,” said Dr. Rod Hochman, president and CEO of Providence St. Joseph. “That resonates with my own family.”
When Hochman’s dad had a stroke, he had to battle with a physician who wanted to prescribe hypothermic therapy and other aggressive treatments, even though the scans showed that the extra effort would ultimately be futile, Hochman said.
“It gave me an appreciation for what we put our patients through all the time. And it helps me appreciate what our clinicians need to do,” he said.
More hospitals are implementing end-of-life or palliative-care programs. The proportion of U.S. hospitals with more than 50 beds that had a palliative-care program tripled from 2000 to 2015, from 25% to 75%, according to a studypublished in Health Affairs last year.
Researchers credited the change to the Center to Advance Palliative Care’s educational efforts and leadership training initiative. About two-thirds of the 1,800 hospitals that now have palliative-care programs participated in the center’s program, even though the dominant fee-for-service reimbursement model does not encourage palliative care.
But new payment models are driving more discussions about palliative care. New codes in the 2016 physician fee schedule meant that doctors would get paid for end-of-life planning.
Nearly 23,000 providers billed Medicare for end-of-life planning appointments on behalf of about 575,000 Medicare beneficiaries in 2016, according to the CMS. Utilization picked up in the second half of the year after 220,000 patients used the services through the first six months of 2016. Providers received $43 million in Medicare reimbursement that year.
The economics are not a barrier anymore, but there are still cultural hurdles, Byock said.
“This is still misinterpreted as being about death or only necessary when someone is seriously ill,” Byock said. “People have to understand that excellence in care needs to be highly tailored to them as a person and not just a problem list.”
Palliative care is an important part of the industry’s value-based mantra and one of its aims to reduce unnecessary care, but it requires difficult conversations about quality of life. Families must weigh whether often financially and physically taxing treatment is worthwhile. Physicians may be reluctant to initiate the conversation if they are already feeling overwhelmed.
About 13% of total healthcare spending was devoted to individuals in their last year of life, according to a study published in the American Public Health Association.
“As health systems do end-of-life care better, it’s better for the overall cost of care and the patients, but also for health systems,” Hochman said.
During another ride back from treatment, Byock’s dad declined an offer to join friends for coffee. He told his son that being sick is embarrassing, and it makes other people uncomfortable. Byock tightened his jaw as he blinked back tears.
His dad’s doctor had the best intentions in offering the radiation therapy, but he was holding on to an unlikely reality at his father’s expense, Byock said.
“We have to acknowledge that we are all mortal,” he said. “We should explore the full use of medical therapy, but in the larger context of a full and healthy human life.”
More Treatments for Multiple Myeloma Could Soon be Available
Within the next six years, the multiple myeloma market is projected to be $37.5 billion – an incredible growth of $30 billion since 2015, when the market was valued at about $7.5 billion.
Market drivers are expected to include the “constant introduction of newer and effective therapeutic options and high adoption rates of the same,” according to an analysis conducted by Grand View Research. Celgene’s blockbuster drug Revlimid is one of the biggest drugs in the multiple myeloma space, bringing in about $2 billion in annual revenue for the company. But more medications could soon be available to treat patients with various forms of the disease.
Multiple myeloma is an incurable cancer found in bone marrow. There are more than 118,000 people living with, or in remission from, multiple myeloma in the United States. Approximately 30,280 Americans are diagnosed with multiple myeloma each year and 12,590 patient deaths are reported on an annual basis, according to the American Cancer Society.
In the last three years the U.S. Food and Drug Administration (FDA) has approved several new therapies aimed at treating multiple myeloma, including Novartis’ Farydak, which was approved in 2015, Janssen’s Darzalex, a CD38-directed antibody that picked up a new indication for multiple myeloma earlier this month; Takeda’s Ninlaro, which was approved by the FDA in 2015; and Empliciti, co-developed by AbbVie and Bristol-Myers Squibb. The new drug approvals have provided some therapeutic benefit to multiple myeloma patients but there are more treatments in development, with some near to seeking FDA approval.
Earlier this month Newton, Mass.-based Karyopharm Therapeutics announced it will seek FDA approval for its investigational drug selinexor following strong top-line results from a Phase IIb trial. Karyopharm said 25.4 percent of refractory multiple myeloma patients on the drug achieved an overall response during the mid-stage trial. Karyopharm said that strong response included two complete responses and 29 partial or very good partial responses. The median duration of response was 4.4 months. With the strong results in hand, as well as the FDA’s Fast-Track designation, the company is aiming to seek approval later this year. Karyopharm said it will request an expedited review in order to potentially make the treatment more readily available for patients. The company also intends to seek regulatory approval in Europe from the European Medicines Agency in early 2019.
Also this month Janssen announced Darzalex in combination with Takeda’s Velcade and prednisone snagged FDA approval for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). Approval was granted based on clinical studies that showed the combination treatment reduced the risk of disease progression or death by 50 percent. Andrzej Jakubowiak, a study investigator and director of the Multiple Myeloma Program at University of Chicago Medical Center, hailed the FDA approval. Jakubowiak said the treatment is the first antibody-based regimen for those transplant-ineligible multiple myeloma patients.
New Jersey-based Celgene is also eying approval for its late-stage multiple myeloma drug. In February the company said its combination treatment of Pomalyst/Imnovid (pomalidomide) plus bortezomib and low-dose dexamethasone met its primary endpoint in progression-free survival in patients with relapsed/refractory multiple myeloma. Celgene said at the time that its triple-combination treatment was the only late-stage drug for patients who have previously been treated with Revlimid (lenalidomide) and had their cancer return. In the late-stage trial the triple combination therapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival, Celgene announced. Paul Richardson, the director of Clinical Research at the Jerome Lipper Multiple Myeloma Center at the Dana Farber Cancer Institute and lead investigator of the Celgene trial, said researchers “see the PVd combination as an important step in improving care, and especially for patients previously treated with lenalidomide in this setting.”
Amgen is also banking on securing a new indication for its multiple myeloma drug Kyprolis. In October 2017 the company released late-stage data that a stronger weekly dose of Kyprolis combined with dexamethasone had a greater progression-free survival benefit of 3.6 months than a twice-weekly dose of the drug at the approved dosing level. The median progression-free survival in the once-per-week group was 11.2 months, compared to the 7.6 months for patients taking the twice-per-week dose combined with dexamethasone.
In addition to the late-stage drugs, there are multiple early and mid-stage drugs that look to be promising. In December 2017 Celgene and bluebird bio released data for an early stage CAR-T therapy for patients with late-stage relapsed/refractory multiple myeloma that yielded promising results. Seattle Genetics, launched a Phase I study in March for SGN-CD48A, an antibody-drug conjugate that has the potential to be used as a monotherapy treatment. The experimental SGN-CD48A targets the CD48 protein, which is highly expressed on multiple myeloma cells. Both of these treatments though are a long way away from becoming a reality for patients. There is a chance that neither one could ever make it to the FDA.
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