Pfiz­er's Paxlovid on­ly helped se­niors avoid hos­pi­tal­iza­tion and death, new NE­JM study finds

Us­age of Pfiz­er’s Covid-19 treat­ment Paxlovid has spiked across the US in re­cent months, with more than 2 mil­lion cours­es ad­min­is­tered dur­ing this lat­est Omi­cron wave since June, po­ten­tial­ly sav­ing many from hos­pi­tal­iza­tion or death.

But a new ob­ser­va­tion­al study pub­lished in the New Eng­land Jour­nal of Med­i­cine on Wednes­day evening found that Paxlovid on­ly worked among pa­tients 65 years of age or old­er, with no ev­i­dence of ben­e­fit found in younger adults.

The Is­rael-based study, which didn’t eval­u­ate the cur­rent Omi­cron vari­ant, looked at al­most 43,000 Covid-19 pa­tients who were 65 or old­er, and found hos­pi­tal­iza­tion oc­curred in 11 pa­tients treat­ed with Paxlovid (14.7 cas­es per 100,000 per­son-days) and in 766 un­treat­ed pa­tients (58.9 cas­es per 100,000 per­son-days).

But among the more than 66,000 Covid pa­tients who were 40 to 64 years old, hos­pi­tal­iza­tion oc­curred in sev­en treat­ed pa­tients (15.2 cas­es per 100,000 per­son-days) and in 327 un­treat­ed pa­tients (15.8 cas­es per 100,000 per­son-days), which wasn’t a sig­nif­i­cant dif­fer­ence.

Walid Gel­lad

Walid Gel­lad, di­rec­tor of the Uni­ver­si­ty of Pitts­burgh’s Cen­ter for Phar­ma­ceu­ti­cal Pol­i­cy and Pre­scrib­ing, who’s un­af­fil­i­at­ed with the study, told End­points News, “We need to re­think how we are us­ing this drug, giv­en these find­ings, and those of Epic-SR [pri­ma­ry end­point not met]. We are over treat­ing [sic] rel­a­tive­ly healthy boost­ed peo­ple un­der 50 who might be el­i­gi­ble for Paxlovid be­cause of one mi­nor risk fac­tor but who are not tru­ly at high risk of de­vel­op­ing se­vere dis­ease.”

Pfiz­er did not im­me­di­ate­ly re­spond to a re­quest for com­ment on the study, but Paxlovid’s au­tho­riza­tion is based on fi­nal re­sults from Pfiz­er’s Epic-HR study, show­ing an 86% re­duc­tion in rel­a­tive risk of hos­pi­tal­iza­tions or death from any cause. Pfiz­er ex­pects Paxlovid to bring in more than $20 bil­lion this year.

While oth­er tri­als have since shown that Paxlovid may not work as well in the vac­ci­nat­ed pop­u­la­tion, Gel­lad not­ed that this Is­raeli study, first post­ed as a pre-print in June, “does show ben­e­fit of the drug in old­er vac­ci­nat­ed and pri­or in­fect­ed in­di­vid­u­als who are old­er and at high risk of pro­gres­sion, and every­one who fits that bill should be of­fered treat­ment. Same with younger high risk who are un­vac­ci­nat­ed or not pre­vi­ous­ly in­fect­ed, in my view.”

But giv­en the rise of Paxlovid’s us­age, many ex­perts are al­so rais­ing con­cerns about re­sis­tance.

“The gov­ern­ment is push­ing this drug too hard to be used at the drop of a hat in every­one with­out enough ev­i­dence that it has suf­fi­cient ben­e­fit to out­weigh known and un­known risks, in­clud­ing the con­tin­ued un­cer­tain­ty around re­bound and the the­o­ret­i­cal risks of re­sis­tance,” Gel­lad added, not­ing that “what we re­al­ly need is a ran­dom­ized tri­al in vac­ci­nat­ed younger peo­ple, which the British will even­tu­al­ly give us, be­cause FDA did not re­quire it here.”

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

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With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Ma­gen­ta halts stem cell work and may sell it­self fol­low­ing pa­tient death, clin­i­cal hold

Magenta Therapeutics said it is halting work on its stem cell transplant drug pipeline and may sell itself, a week after the company reported the death of a patient in an early stage trial of its antibody-drug conjugate.

The Cambridge, MA-based company said it will conduct a “review of strategic alternatives,” and that could include an “acquisition, merger, business combination, or other transaction.”

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Photo: Julia Weeks/AP Images

FDA ax­es re­quire­ment for pos­i­tive Covid test be­fore Paxlovid use

FDA announced today that doctors and pharmacists can now prescribe Paxlovid to patients without a positive test for Covid-19.

CDER Director Patrizia Cavazzoni reissued Paxlovid’s authorization letter Wednesday, saying it has revised the authorization to “no longer require positive results of direct SARS-CoV-2 viral testing.” The EUA now requires instead that adults and kids 12 years of age and older have a “current diagnosis of mild-to-moderate COVID-19.”

Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.