BREAKING: 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, 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.

But 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 of each, it re­mains un­known who ex­act­ly may get ac­cess. The US may have about 400,000 cours­es of Mer­ck’s pill avail­able in the next few days, and 65,000 cours­es of Pfiz­er’s pill, ac­cord­ing to a Bloomberg re­port from this morn­ing.

But by the end of Jan­u­ary, the US gov­ern­ment ex­pects to have about 3 mil­lion cours­es of Mer­ck’s pill and 250,000 of Pfiz­er’s.

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.

CALQUENCE is a registered trademark of the AstraZeneca group of companies.

At the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition, blood cancer researchers from around the world gathered virtually to discuss the progress that has been made in the field of hematology. Over the past decade, that progress has been tremendous. We’ve seen not only breakthrough approaches to care, but also significant improvement upon existing novel treatments and exploring combinations within those medicines.1 These advances have transformed expectations of what a blood cancer diagnosis now means for patients. While we’ve come a long way, I believe the most exciting scientific discovery is yet to come, and that future advances will truly transform patient care.

Angie You and Volker Schellenberger, Amunix

Sanofi is crashing the year-end M&A party with a deal of its own.

Immuno-oncology is the name of the game as it swallows Mountain View, CA-based Amunix for $1 billion upfront and up to $225 million in biobucks, tagging a suite of T cell engagers and cytokine therapies as well as a tech platform for making ‘conditionally activated biologics.’

‘The Amunix technology platform utilizes a next generation smart biologics approach to precisely tailor-deliver medicines to become active only in tumor tissues while sparing normal tissues,’ said Sanofi R&D chief John Reed, ‘thus bringing the promise of more effective and safer treatment options for cancer patients.’

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Khurem Farooq, Gyroscope CEO

Christmas is coming early for Gyroscope.

In its latest gene therapy gambit, Novartis is paying $800 million upfront to acquire the Syncona-backed biotech, with another $700 million reserved for milestones.

Novartis has been diving deep into retinal disorders, and Gyroscope’s lead candidate adds a potential one-time treatment for geographic atrophy — a leading cause of blindness — to the pipeline.

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Christophe Weber (Miho Takahashi/The Yomiuri Shimbun via AP Images)

Takeda CEO Christophe Weber thought he had a win in the bag for TAK-721 — one of the experimental drugs spotlighted in the company’s $62 billion Shire acquisition — and went so far as to announce a brand name after snagging priority review last year. But months after missing its PDUFA date, the FDA’s now saying better luck next time.

Regulators handed TAK-721 a complete response letter for the treatment of eosinophilic esophagitis (EoE), a chronic inflammatory disease of the esophagus, Takeda revealed on Tuesday. While the pharma company didn’t share much information on the FDA’s reasoning behind the rejection, execs shared that the agency has recommended an additional clinical study ‘in order to help resolve FDA feedback.’

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Alzheimer’s disease researchers along with medical professors from Harvard and Johns Hopkins issued a formal statement Monday asking the FDA to quickly pull Biogen’s Aduhelm from the market.

‘An accelerated withdrawal would mitigate some of the harm of its unwarranted accelerated approval,’ they wrote to FDA, explaining how Aduhelm ‘did not meet the FDA’s own criteria for accelerated approval based on surrogate markers because amyloid plaque does not correlate well with symptoms, severity of disease or progression.’

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As the FDA is poised to authorize the new Pfizer and Merck pills to treat those with Covid-19 who haven’t been hospitalized, Bloomberg reports that the US will only have limited supplies of each pill initially.

US officials said Americans should have nearly 400,000 courses of Merck’s pill available upon its authorization and 65,000 courses of Pfizer’s pill. By the end of January, the government expects 3 million Merck courses — its entire order — and 250,000 Pfizer courses. Merck’s pill has been shown to be less effective in early trials than Pfizer’s, although Merck did not test its pill head-to-head against Pfizer.

Graphic: Alexander Lefterov for Endpoints News

Drug pricing reform has been a political football for years, with both Donald Trump and Joe Biden championing changes during their presidencies. Little has moved the needle on Capitol Hill, however, thanks in part to the drug industry’s powerful lobbyists.

In the most recent example, Democrats tried to allow Medicare to negotiate drug prices — an immediate non-starter for biopharma proponents. After months of negotiation, the measure fell apart in favor of provisions on a small subset of drugs that passed the House but marked a far cry from Biden’s promises and what many activists had hoped for. The bill, included as part of Biden’s broad social policy agenda, now appears dead after Democrats failed to secure 50 votes in the Senate.

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Right as the new Omicron variant is poised to increase rapidly across the US, the federal government has effectively run out of the only monoclonal antibody treatment that works against it, and at least one major hospital system is now halting all mAb infusions.

Late last month, the federal government paused shipments of GlaxoSmithKline and Vir’s mAb treatment sotrovimab in order to conserve supplies of the only treatment that might work against the Omicron variant. Last week, however, HHS told Endpoints News that the move to hold back sotrovimab was unrelated to Omicron, and due to a surplus of Eli Lilly mAbs, which aren’t effective against Omicron.

Another bad week for Biogen and its Tokyo-based partners at Eisai was extended on Wednesday with news that a panel review of their controversial Alzheimer’s drug aducanumab earned a pushback from the health ministry in Japan.

According to overnight news reports, their panel concluded that inconsistent Phase III data and lack of clinical significance in reducing amyloid plaque in patients made it difficult to determine if the therapy worked, but offered to review it again once the 2 partners lined up more data.
https://endpts.com/breaking-fda-authorizes-the-first-at-home-pills-from-pfizer-to-treat-covid-19/