(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.

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; 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.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

HHS Secretary Xavier Becerra (Jacquelyn Martin/AP Images)

HHS fin­ish­es off Trump-era rule that would've erased ba­sic FDA regs with­out fre­quent re­views

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.

Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Sen. Bill Cassidy (R-LA) (J. Scott Applewhite/AP Images)

Sen­ate un­veils its ver­sion of ac­cel­er­at­ed ap­proval re­forms as bi­par­ti­san duo calls on FDA and PTO to work to­geth­er

The Senate is joining its House counterparts and advancing accelerated approval pathway reforms to the FDA user fee legislation that must be signed by President Joe Biden before the end of September or else the FDA will have to start laying off its staff.

While Sen. Richard Burr (R-NC) warned yesterday that the user fee deals could be delayed by the infant formula crisis, the newly introduced bill on Friday shows how the Senate is aligning with its House counterparts on similar accelerated approval reforms.

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Covid-19 roundup: CDC study shows good pro­tec­tion from mR­NA boost­er plus J&J's sin­gle-dose vac­cine; White House launch­es test-to-treat Paxlovid site

Concerns about rare but life-threatening blood clots have limited the use of J&J’s Covid-19 vaccine — once pitched as the only one-shot option in the mix — with the FDA cutting it off except in limited circumstances. Yet there’s some good news for those who did receive it: A single booster dose of an mRNA vaccine for recipients of a single priming dose of Ad26.COV2.S (the J&J vaccine) provided protection close to that of a three-dose mRNA vaccine regimen.

Co-CEOs Chintu and Chirag Patel (Amneal)

Look out, Neu­las­ta: A 5th biosim­i­lar is com­ing

As Neulasta sales slip, Amgen has yet another biosimilar to look out for: Amneal Pharmaceuticals and Kashiv Biosciences’ Flynetra.

Flynetra became the fifth approved biosimilar to Neulasta on Friday, snagging a win in neutropenia, a condition common among chemotherapy patients where neutrophils, a type of white blood cell that fights infection, are too low.

As of last summer, the list price of Neulasta was more than $6,400 per dose. It’s designed to be taken in a single dose per chemotherapy cycle. Amneal declined to reveal how much it intends to charge for Flynetra in an email to Endpoints News.