Covid-19 roundup: Ahead of FDA, EU signs off on Mer­ck­'s an­tivi­ral; Dis­tri­b­u­tion of mAbs in US see first uptick in 7 weeks

The Eu­ro­pean Med­i­cines Agency on Fri­day said that Mer­ck’s an­tivi­ral mol­nupi­ravir can now be used to treat adults with Covid-19 who do not re­quire sup­ple­men­tal oxy­gen and who are at in­creased risk of de­vel­op­ing se­vere dis­ease.

The pill, known com­mer­cial­ly in Eu­rope as Lagevrio, has not yet been au­tho­rized in the US and has to be tak­en twice a day for 5 days. The EMA said it should be ad­min­is­tered as soon as pos­si­ble af­ter di­ag­no­sis of Covid, and with­in 5 days of the start of symp­toms. The quick au­tho­riza­tion is based on da­ta show­ing the drug re­duced the chance that a new­ly di­ag­nosed Covid-19 pa­tient would be hos­pi­tal­ized or die by 50%, ac­cord­ing to da­ta pre­sent­ed by the com­pa­ny in Oc­to­ber.

There are some safe­ty con­cerns too, as the EMA notes:

Lagevrio is not rec­om­mend­ed dur­ing preg­nan­cy and in women who can be­come preg­nant and are not us­ing ef­fec­tive con­tra­cep­tion. Women who can be­come preg­nant must use ef­fec­tive con­tra­cep­tion dur­ing treat­ment and for 4 days af­ter the last dose of Lagevrio. Breast­feed­ing should be in­ter­rupt­ed dur­ing treat­ment and for 4 days af­ter treat­ment. These rec­om­men­da­tions are giv­en as lab­o­ra­to­ry stud­ies in an­i­mals have shown that high dos­es of Lagevrio can im­pact the growth and de­vel­op­ment of the foe­tus.

Mean­while, the EMA is al­so re­view­ing Pfiz­er’s oral an­tivi­ral too, which showed an 89% re­duc­tion in risk of Covid-re­lat­ed hos­pi­tal­iza­tion or death from any cause com­pared to place­bo. The FDA is cur­rent­ly re­view­ing EUA ap­pli­ca­tions for both drugs.

Dis­tri­b­u­tion of mAb treat­ments for Covid-19 in US see first uptick in 7 weeks

As the Delta vari­ant surged in cer­tain ar­eas of the US with low vac­ci­na­tion rates, the As­sis­tant Sec­re­tary for Pre­pared­ness and Re­sponse said it saw a 20-fold in­crease in or­ders for mon­o­clon­al an­ti­body ther­a­peu­tics (mAbs) to treat Covid-19.

In re­sponse to this in­crease in de­mand, AS­PR tran­si­tioned to a mAb dis­tri­b­u­tion sys­tem that’s co­or­di­nat­ed by states and ter­ri­to­ries in Sep­tem­ber. While some states like Michi­gan and Penn­syl­va­nia have seen in­creas­es in mAb sup­plies from GSK/Vir, Re­gen­eron and Eli Lil­ly’s prod­ucts, over­all as a coun­try, the num­ber of mAbs dis­trib­uted steadi­ly de­clined from al­most 200,000 dos­es dis­trib­uted in the week of Sept. 21, to on­ly about 100,000 dos­es dis­trib­uted na­tion­wide for the week of Nov. 8.

Now, per­haps in prepa­ra­tion for ris­ing num­bers of in­fec­tions as the win­ter months take hold, that num­ber of mAb dos­es dis­trib­uted has sky­rock­et­ed back up to about 175,000 dos­es dis­trib­uted na­tion­wide. Whether that’s just an­oth­er fluc­tu­a­tion in the week-to-week dis­tro sys­tem re­mains to be seen.

Over­all, the num­ber of dos­es dis­trib­uted by Re­gen­eron con­tin­ues to out­pace those shipped from GSK and Lil­ly, and an­oth­er com­peti­tor may hit the mar­ket next year.

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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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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.

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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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.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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