(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.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

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Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Pfizer officially scooped up Biohaven’s CGRP assets on Monday, including blockbuster migraine drug Nurtec and the investigational zavegepant, for $11.6 billion. As a result, Coric spun the broader pipeline into an independent company on Tuesday — with the same R&D team behind Nurtec but about 1,000 fewer staffers and a renewed focus on neuroscience and rare disease.

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Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Lentivi­ral vec­tor ramp-up: J&J and Leg­end to in­vest $500M in New Jer­sey man­u­fac­tur­ing to sup­port Carvyk­ti

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