(Photo courtesy Pfizer)

FDA au­tho­rizes the first at-home pills from Pfiz­er to treat Covid-19

The FDA on Wednes­day signed off on Pfiz­er’s Covid-19 pills, which are meant to help keep peo­ple out of the hos­pi­tal.

The news comes at a cru­cial mo­ment, as the Omi­cron vari­ant has tak­en over Delta as the promi­nent strain in the US, and as mon­o­clon­al an­ti­body in­fu­sions will like­ly be in very short sup­ply as two of the three cur­rent­ly mar­ket­ed are in­ef­fec­tive against Omi­cron.

Pfiz­er will see ear­ly sup­ply con­straints of their pills, which are made up of nir­ma­trelvir tablets and ri­ton­avir tablets, co-pack­aged for oral use, mean­ing doc­tors will have to be very care­ful on how they’re doled out. And if Mer­ck’s pill is au­tho­rized soon too, there may be more op­tions, al­though there’s al­so a dras­tic dif­fer­ence in ef­fi­ca­cy be­tween the two.

“I don’t think you would find any­one who would pre­fer the Mer­ck pill to the Pfiz­er pill, giv­en the da­ta ev­i­dent so far,” Walid Gel­lad, a pro­fes­sor of med­i­cine at the Uni­ver­si­ty of Pitts­burgh, told End­points News.

Mer­ck’s pill saw its ef­fi­ca­cy plum­met be­tween in­ter­im and fi­nal analy­ses in its piv­otal tri­al — from a 50% rel­a­tive re­duc­tion in hos­pi­tal­iza­tions and deaths at the in­ter­im to just 30% in the fi­nal re­sults — mean­ing that more doc­tors will like­ly re­ly on the Pfiz­er pill. There are al­so ques­tions about how Mer­ck’s pill works, which led France’s ex­perts to re­ject it.

Pfiz­er, mean­while, re­cent­ly said that its pill, known com­mer­cial­ly as Paxlovid, proved to re­duce the rel­a­tive risk of hos­pi­tal­iza­tion or death by 89% (with­in three days of symp­tom on­set) and 88% (with­in five days of symp­tom on­set) com­pared to place­bo in a tri­al of more than 2,000 peo­ple.

The FDA al­so said in the EUA’s health care provider fact sheet that the pill should stand up against the Omi­cron vari­ant, but the FDA did not re­view the pill be­fore an ad­comm so most of the tri­al da­ta has on­ly been re­leased in Pfiz­er press re­leas­es so far. And all pa­tients in the Pfiz­er tri­al had not re­ceived a Covid-19 vac­cine.

Gel­lad warned that the “ben­e­fit of the pills def­i­nite­ly goes down in vac­ci­nat­ed peo­ple, and the mag­ni­tude of that re­duc­tion in ben­e­fit is still not clear. We on­ly got pre­lim­i­nary da­ta in the press re­lease about im­pact on high-risk vac­ci­nat­ed peo­ple in the non-com­plet­ed tri­al. There will be some ben­e­fit, but pre­sum­ably not near­ly the im­pact as on un­vac­ci­nat­ed.”

The Pfiz­er pill is au­tho­rized for those over 12 years of age, weigh­ing at least 88 pounds, with pos­i­tive re­sults of di­rect SARS-CoV-2 test­ing, and who are at high risk for pro­gres­sion to se­vere Covid, in­clud­ing hos­pi­tal­iza­tion or death. But there are cer­tain re­stric­tions, with FDA say­ing Paxlovid is not rec­om­mend­ed in pa­tients with se­vere kid­ney or se­vere liv­er im­pair­ment, adding:

Be­cause Paxlovid works, in part, by in­hibit­ing a group of en­zymes that break down cer­tain drugs, Paxlovid is con­traindi­cat­ed with cer­tain drugs that are high­ly de­pen­dent on those en­zymes for me­tab­o­lism and for which el­e­vat­ed con­cen­tra­tions of cer­tain drugs are as­so­ci­at­ed with se­ri­ous and/or life-threat­en­ing re­ac­tions. Paxlovid is al­so con­traindi­cat­ed with drugs that, con­verse­ly, strong­ly in­duce those same en­zymes, lead­ing to the faster break­down of nir­ma­trelvir or ri­ton­avir, as re­duced con­cen­tra­tions of nir­ma­trelvir or ri­ton­avir may be as­so­ci­at­ed with po­ten­tial­ly los­ing vi­ro­log­ic re­sponse and de­vel­op­ing vi­ral re­sis­tance. Paxlovid can­not be start­ed im­me­di­ate­ly af­ter dis­con­tin­u­ing such med­ica­tions be­cause the ef­fects of those med­ica­tions re­main af­ter dis­con­tin­u­a­tion.

But with very lim­it­ed sup­plies ini­tial­ly (65,000 cours­es are ship­ping the first week of Jan­u­ary), on­ly a hand­ful of states will see more than 3,000 cours­es of Paxlovid in that first week next month.

“An ad­di­tion­al 200,000 cours­es are ex­pect­ed in Jan­u­ary, ramp­ing up steadi­ly in the months ahead,” HHS said of Pfiz­er’s pill. The US has bought 10 mil­lion cours­es, and Pfiz­er said in a state­ment that it al­so raised pro­duc­tion pro­jec­tions from 80 mil­lion to 120 mil­lion cours­es of treat­ment in 2022, as a re­sult of con­tin­ued in­vest­ments.

The US al­so may have about 400,000 cours­es of Mer­ck’s pill avail­able in the next few days, if au­tho­rized, ac­cord­ing to a Bloomberg re­port. But by the end of Jan­u­ary, the US gov­ern­ment ex­pects to have about 3 mil­lion cours­es of Mer­ck’s pill.

Al­so by the end of Jan­u­ary, the US will have about 300,000 cours­es of the Glax­o­SmithK­line and Vir mAb treat­ment, and an­oth­er 55,000 dos­es were shipped out this week.

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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Elcin Barker Ergun, Menarini Group CEO

Amid Roche and Sanofi's oral SERD set­backs, Menar­i­ni gets speedy re­view at FDA

Menarini and Radius Health are getting a speedy review at the FDA for their oral SERD breast cancer drug months after the field opened up with competitors failing and fleeing.

It was a one-two-three punch in March, April and May as Sanofi flunked its first big test for its oral selective estrogen receptor degrader (SERD), Roche also flamed out in a Phase II and G1 Therapeutics ended its program after scoping out the data and potential partners.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.