Omicron pushes U.S. COVID hospitalizations toward record high

 

COVID-19 hospitalizations in the United States are poised to hit a new high as early as Friday, according to a Reuters tally, surpassing the record set in January of last year as the highly contagious Omicron variant fuels a surge in infections.

Hospitalizations have increased steadily since late December as Omicron quickly overtook Delta as the dominant coronavirus variant in the United States, although experts say Omicron will likely prove less deadly than prior iterations.

While potentially less severe, health officials have warned that the sheer number of infections caused by Omicron could strain hospital systems, some of which have already shown signs of distress, partly due to staffing shortages.

"I don't believe we've seen the peak yet here in the United States," Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky told NBC News' "Today" program on Friday, as schools and businesses also struggle with rising caseloads.

The United States reported 662,000 new COVID-19 cases on Thursday, the fourth highest daily U.S. total coming just three days after a record of nearly 1 million cases was reported, according to the Reuters tally.

The seven-day average for new cases set a record for a 10th consecutive day at 597,000, while COVID hospitalizations reached nearly 123,000 and appeared poised to top the record of over 132,000 set last year.

Deaths, an indicator that lags hospitalizations, remain fairly steady at a still high 1,400 a day, according to the tally, well below last year's record numbers.

CAUTIOUSLY OPTIMISTIC

New York Governor Kathy Hochul and the head of one of the largest U.S. hospitals both said they were cautiously optimistic that cases and hospitalizations would soon plateau in the state.

"We think with our modeling that the peak will happen next week," said Steven Corwin, chief executive of New York-Presbyterian Hospital, during Hochul's daily briefing.

Delaware, Illinois, Maryland, Pennsylvania, Ohio, Vermont and Washington, D.C., all reported record levels of hospitalized COVID patients in recent days, according to the Reuters analysis.

Hospitalization data, however, does not differentiate between people admitted for COVID-19 and so-called incidental positives. Those are patients who were admitted and treated for issues other than COVID-19 and contracted the virus while in the hospital and are counted in coronavirus hospitalization numbers.

Incidental infections have occurred throughout the pandemic but might be significantly higher now due to the staggering pace of Omicron's spread - a phenomenon that has prompted state health departments to consider altering their disclosures.

Starting next week, Massachusetts hospitals will report whether admissions are primary or incidental to COVID-19, said Kathleen Conti, a spokesperson for the state's department of health.

Rising cases have forced hospital systems in nearly half of U.S. states to postpone elective surgeries.

While many school systems have vowed to continue in-person instruction, some have faced ad hoc closures as cases rise. Chicago Public Schools, the third-largest U.S. school system, were closed for a third day on Friday amid a teacher walkout over COVID-19 protections.

U.S. and other officials have said schools can be safely opened, especially with widely available vaccines and boosters, and the CDC on Thursday issued new isolation policy guidelines for schools.

Officials continue to press vaccinations as the best protection against serious illness, although federal mandates requiring them have become politically contentious.

U.S. Supreme Court justices on Friday grilled Republican state officials and business groups seeking to block President Joe Biden's vaccine-or-testing mandate for large businesses and pressed the administration to justify the policy at a time of surging COVID-19 cases nationwide.

The U.S. Food and Drug Administration on Friday shortened the interval between the primary series of the Moderna COVID-19 vaccine and a booster dose from six months to five for people aged 18 or older. The regulatory decision comes days after the agency made a similar move for getting a booster shot of the Pfizer and BioNTech COVID-19 vaccine. The Pfizer booster has also been authorized for use in children aged 12 to 15.

https://www.marketscreener.com/news/latest/Omicron-pushes-U-S-COVID-hospitalizations-toward-record-high--37489866/

Revance Therapeutics Rises After FDA Meeting on DAXI

 

 Shares of Revance Therapeutics Inc. moved higher Friday after the biotechnology company reported progress in its pursuit of U.S. Food and Drug Administration approval of its injection treatment for frown lines.

The Newark, Calif., company said it held a so-called "Type A" meeting with the FDA, which in October said it wouldn't approve Revance's application for DaxibotulinumtoxinA for Injection, or DAXI, due to issues related to the drug's manufacturing plant.

According to FDA guidelines, Type A meetings are aimed at resolving disputes and helping stalled product development programs proceed, with scheduling targeted to occur within 30 days of receipt of a written request.

Revance said it believes the meeting has informed its next steps for a resubmission, adding that it will provide an update on the regulatory pathway once it receives the formal meeting minutes from the FDA.

Analysts at Wells Fargo said it is encouraging that Revance has already met with the FDA, given fears that the Covid-19 pandemic and the holiday season might delay a meeting until later in the first quarter. Wells Fargo said it is modeling a late 2022 approval for DAXI.

Revance also on Friday reported preliminary RHA filler revenue of $23 million to $24 million, which analysts at Wells Fargo and Mizuho say tops expectations.

https://www.marketscreener.com/quote/stock/REVANCE-THERAPEUTICS-INC-15724812/news/Revance-Therapeutics-Rises-After-FDA-Meeting-on-DAXI-37492581/

Biogen's Aduhelm faces key coverage decision next week. Which way will Medicare rule?

 Amid its sputtering launch, Biogen expects to receive a draft decision on Aduhelm’s coverage on Medicare next week. Industry watchers have been calculating a range of potential scenarios, but whichever direction the ruling goes, doctor feedback suggests it may simply not matter that much.

A reimbursement decision on Aduhelm in Alzheimer’s disease from the Centers for Medicare and Medicaid Services (CMS) could go five different ways, with one that appears to be the most probable, a Jefferies team led by analyst Michael Yee wrote in a note this week. The government agency is due to deliver a preliminary decision on whether to cover the drug for elderly people by Jan. 12, with a final verdict scheduled for April.

Even with coverage in place, doctors may still refuse to prescribe the controversial Alzheimer’s drug. After Aduhelm’s approval, the Neurology Center in Washington, D.C., went so far as to ban Biogen sales reps from entering the offices.

Major health systems like Cleveland Clinic, Mount Sinai and Mass General Brigham, plus many university-affiliated hospitals at Johns Hopkins, University of California Los Angeles and the University of Michigan, have either boycotted Aduhelm or never prescribed it, Stat reports.

Some facilities already told the news site they don’t expect to change their stance even if CMS decided to cover Aduhelm.

Such a national coverage decision could be “tricky” from a financial perspective, the Jefferies analysts said, “because it could be complicated for the market to understand or interpret, and the market may not give full credit anyway in this tough market.”

An outright rejection could be one scenario. But that's only theoretical given the CMS hasn't refused coverage for an FDA-approved therapy in the last 15 years, the team noted.

CMS could also choose to limit coverage to the med's FDA indication. After an initial approval in June with a surprisingly broad label, Biogen and the FDA got together to restrict the label to patients with mild Alzheimer’s.

Alternatively, CMS could add additional coverage restrictions, further limiting the patient population, Yee’s team said. For example, patients carrying a genetic risk factor called APOE4 have been found to be more likely to experience a potentially life-threatening brain side effect called amyloid-related imaging abnormalities (ARIA) while on Aduhelm. The FDA label doesn’t exclude that patient group.

Yee labeled the above two scenarios as positive decisions that would provide “reimbursement consistency.” Two other situations are less favorable for the drug.

The CMS could install coverage with an evidence development requirement. Under this pathway, reimbursement is offered under the condition of the patient’s participation in a clinical trial. Doing so will obviously limit the drug’s availability to big trial sites, the Jefferies team noted.

In the fifth scenario, the CMS would leave coverage to the discretion of Medicare Administrative Contractors. These are private health insurers that would arguably be more restrictive in their reimbursement decisions.

A decision in the latter two categories could slow the sales ramp and fuel the debate on peak sales potential for all amyloid beta-targeting antibodies like Aduhelm, Yee said. Eli Lilly is wrapping up a rolling submission of rival drug donanemab to the FDA, and Roche could have phase 3 readout from its gantenerumab in the latter half of 2022.

Among the five options, Yee figured coverage with evidence development (CED) is the most likely result. But investors may be confused by what a CED restriction would mean for Aduhelm, he added.

In a recent Bloomberg Opinion piece, drug pricing researcher Peter Bach of Delfi Diagnostics and University of California, San Francisco, cardiologist Rita Redberg also threw their support behind the CED pathway.

Cantor Fitzgerald analyst Louise Chen believes CED and coverage with specified restrictions are the most likely outcomes, as well. Additional restrictions could give CMS more flexibility as more data read out, she said in a Tuesday note to clients.

Before the closely watched Medicare decision, Biogen made an unusual go-big-or-go-home move by slashing Aduhelm’s price in half to an annual maintenance cost of $28,200 for a patient weighing 74 kg (163 pounds).

Biogen’s hope is that the CMS will consider the lowered price in its decision. The company now estimates that about 50,000 patients would start on Aduhelm in 2022 if coverage were in place. That would mean $1.4 billion in annual sales after 2022. By contrast, Wall Street consensus has the drug’s sales at around $400 million to $500 million, which Yee believes is still too high.

Aside from potential Medicare coverage, reimbursement for PET scan of beta-amyloid also needs to improve for Aduhelm to achieve better market penetration, Yee pointed out. The FDA label currently requires these tests before starting treatment and prior to the 7th and 12th infusions to monitor for ARIA.

https://www.fiercepharma.com/pharma/biogen-could-learn-alzheimer-s-aduhelm-s-medicare-fate-next-week-which-way-will-decision-go

Regeneron hands over Evkeeza rights to Ultragenyx outside US

 After nabbing U.S. and European approvals in the past year, Regeneron is shipping the sales and development rights to its ultrarare cholesterol drug Evkeeza over to rare disease specialist Ultragenyx.

The drug launched in the U.S. just under a year ago after nabbing an FDA green light to lower the sky-high cholesterol seen in homozygous familial hypercholesterolemia (HoFH), an ultrarare genetic condition that causes “bad” fats in the blood to shoot up, dramatically raising the risk of heart issues at a young age and fatality before a patient hits 30.  

It affects around four people in every 1 million, and, because of the scarcity of patients, the drug’s cost is enormous, with a list price of about $450,000 per year on average.

Regeneron has another HoFH therapy, PCSK9 drug Praluent, which nabbed approval in the U.S. last April. Both Praluent and Evkeeza rival Amgen’s PCSK9 Repatha, which had that indication before Regeneron.

Regeneron is keen, however, to point out that Evkeeza is a first of its kind therapy and works on a completely different pathway from PCSK9 drugs; thus, it hopes to eke out an advantage in the market.  

The drug also grabbed an approval in Europe last summer, but today the pharma announced it would be handing over Evkeeza rights there and elsewhere outside the U.S. to Ultragenyx.

The deal breaks down like this: Regeneron gets $30 million upfront from the biopharma but can also look forward to $63 million in biobucks and sales milestones, with Ultragenyx also making payments to Regeneron based on net sales. Ultragenyx can work on the drug outside of the U.S. for HoFH and “other potential indications,” according to a statement.

There’s also a bonus asset thrown into the mix, with Regeneron offering Ultragenyx the opportunity to work on a late-stage antibody, also for ultrarare disease, namely fibrodysplasia ossificans progressiva (FOP), “under terms to be agreed upon by both companies.” The companies did not give further details of the therapy or financials involved.

Ultragenyx has several of its own rare disease drugs including FGF23 hormone blocker Crysvita for tumor-induced osteomalacia and X-linked hypophosphatemia as well as Dojolvi, a metabolic supplement for a rare group of disorders, and Mepsevii to treat children and adults with mucopolysaccharidosis VII.

While clearly wanting the focus in the U.S., and the sales, selling an ultrarare drug outside the country requires a lot of work, contacts and ability to help find and diagnose these patients. Many patients can go years without a diagnosis, all within the constraints of differing marketing challenges, such as in Europe, where direct-to-consumer marketing is not allowed.

The best thing to do? Hire a specialist. A Regeneron spokesperson told Fierce Pharma Marketing that its choice of partner made all the difference. “While we are growing our ex-U.S. presence, in the case of Evkeeza, we saw real benefit with partnering with Ultragenyx, which has a focus on serious genetic diseases and deep relationships in countries outside of the U.S.”

Regeneron said it has “been actively engaging in discussions regarding current needs and efforts underway and are working closely together to ensure an expedited onboarding and smooth transition of responsibilities outside of the United States.”

In the U.S., the pharma is also working on Evkeeza in children with HoFH as well as adult patients with severe hypertriglyceridemia, a more common condition in which triglyceride levels are elevated, to help prevent of recurrent acute pancreatitis.

https://www.fiercepharma.com/marketing/regeneron-hands-over-evkeeza-rights-to-ultragenyx-outside-u-s-a-r-d-asset-also-thrown

White House finalizing USPS deal to deliver 500M COVID-19 tests: report

 Plans to deliver 500 million COVID-19 test kits to homes are being finalized between the White House and U.S. Postal Service, and officials hope by mid-January to start shipping those tests out, The Washington Post reported, citing four people familiar.

A website that will allow people to submit COVID-19 rapid test requests will also be established by the administration, those people told the newspaper.

Separately, negotiations regarding extending the seasonal employees who were hired during the holidays by the Postal Service are happening between its four labor unions and the agency.

One person familiar told the Post that the first contract was awarded on Thursday after proposals had been offered to the government amongst distributors and test manufacturers who intend on providing COVID-19 tests to the initiative.

A request for comment from the Postal Service was not immediately returned to the Post. A representative for the White House declined to comment to the newspaper about the matter. 

The development comes several weeks after President Biden announced that 500 million COVID-19 tests had been purchased by the administration to be given to all Americans who wanted one as the U.S. deals with a surge in cases due to the highly transmissible omicron variant.

COVID-19 tests can help Americans make informed decisions on how to safely gather with family and friends during the pandemic. Initial data and research suggest that the omicron variant may not be as severe as health officials initially worried, though it is considered highly transmissible.

Efforts to find rapid COVID-19 tests have been challenging for many Americans, as many retailers have completely sold out of their shipments of the critical coronavirus supplies. President Biden said in an interview with ABC’s David Muir last month that he did not think “it’s a failure” that there was a current shortage of tests.

"You could argue that we should have known a year ago, six months ago, two months ago, a month ago."

However, he did say that he wished he had thought about ordering those tests earlier.

"I wish I had thought about ordering half a billion [tests] two months ago," Biden said.

The Hill has reached out to the White House and Postal Service for comment.

https://thehill.com/homenews/administration/588704-white-house-finalizing-deal-with-usps-to-deliver-500-million-covid-19

Walensky: US has not yet seen omicron peak

Rochelle Walensky, director of the Centers for Disease Control and Prevention (CDC), said on Friday that she does not think the U.S. has yet reached the peak of the omicron surge. 

With the seven-day average of COVID-19 cases almost doubling from last week, Walensky told NBC's “Today” that she does not think the U.S. is experiencing what South Africa saw when concluding it “may have passed the peak.”

“The way it has peaked in other countries — in South Africa, it has come down rapidly as well,” she said. “But I don’t believe we’ve seen that peak here in the United States.”

Walensky reported on Wednesday that the average daily cases reached 491,700 infections, after reaching a high of nearly 1 million cases confirmed on Monday. 

In her “Today” interview, she noted that COVID-19 hospitalizations and deaths are climbing at a slower rate than cases, but “we’re now starting to see the number of hospitalizations rise as well.”

Hospitalizations reached a seven-day average of about 14,800 per day in a 63 percent increase from the previous week, Walensky said on Wednesday. Deaths rose 5 percent to approximately 1,200 per day. 

But hospitals across the country are filled with unvaccinated patients who are 17 times more likely to be admitted and 20 times more likely to die than boosted individuals, the CDC director told “Today.”

“So there’s a lot we can do right now in this moment getting vaccinated, getting boosted,” she said. “We have 99 percent of our counties in high transmission. Wear your mask in public indoor settings.”

https://thehill.com/policy/healthcare/588724-walensky-us-has-not-yet-seen-omicron-peak

Appeals court grapples over next steps in Texas abortion law case

 A federal appeals court on Friday grappled with how to proceed with a legal challenge against the controversial Texas abortion law known as SB 8 after the Supreme Court declined to strike it down but allowed lawsuits against it to move forward.

During a hearing, a three-judge panel for the Fifth Circuit Court of Appeals heard arguments from lawyers for the state and abortion providers challenging the law, who disagree on procedural issues over the next steps for the case.

Two of the three judges, both appointed by Republican presidents, appeared sympathetic towards Texas's argument that the case should be sent to the state's supreme court for further litigation over the law. Abortion providers argue that the case should be returned to the federal district court and have even asked the Supreme Court to intervene to prevent the Fifth Circuit from stalling the case.

"Any further delay would be inconsistent with how the Supreme Court has handled this case," Marc Hearron, an attorney for the plaintiffs, said during Friday's hearing.

Judge Kyle Duncan responded by saying that the Supreme Court did not outline how the case should proceed.

"I really question that premise Mr. Hearron, because the Supreme Court had multiple opportunities to grant an injunction against SB 8, to send it directly to the district court, and it didn't do any of that," said Duncan, who was appointed by former President Trump.

The issue now before the Fifth Circuit involves extremely technical procedural issues, but how it's decided could determine the pace of the remaining legal challenges.

SB 8 bans abortion procedures after six weeks into a pregnancy, which many legal scholars say flies in the face of previous Supreme Court precedent. But the law was designed to frustrate judicial review with a provision that leaves enforcement entirely to private individuals filing civil suits against medical personnel or anyone else who facilitates the banned procedures.

In December, the Supreme Court narrowed the abortion providers' suit, but allowed it to proceed against certain Texas licensing officials, while dismissing a legal challenge from the Biden administration.

The high court remanded the case to the Fifth Circuit, which abortion providers believe is disinclined to handle the lawsuit with the appropriate urgency.

Lawyers for the reproductive clinics took the extraordinary step this week of asking the Supreme Court to step in and order the circuit court to dispatch the case to the district court level where the next steps can be litigated.

"Absent intervention by the Court, the Fifth Circuit is poised to entertain questions already decided by the Court in direct violation of this Court’s mandate, and delay further resolution of this case in the district court by at least weeks, and potentially months or more," Hearron wrote in a Supreme Court brief on Monday. "Therefore, Petitioners have no recourse in any other court."

It's unclear when the Fifth Circuit or the Supreme Court will rule in the case.

https://thehill.com/regulation/court-battles/588743-appeals-court-grapples-over-next-steps-in-texas-abortion-law-case