FDA re­ports more short­ages of drugs used to put Covid-19 pa­tients on ven­ti­la­tors

In­creas­ing de­mand for seda­tives used to help put Covid-19 pa­tients on­to ven­ti­la­tors means the FDA added two more — this time the in­jecta­bles propo­fol and dexmedeto­mi­dine — to its list of drug short­ages.

Michael Ganio

The propo­fol short­age was al­so pre­vi­ous­ly list­ed by the Amer­i­can So­ci­ety for Health-Sys­tem Phar­ma­cists (ASHP) ear­li­er this month, with man­u­fac­tur­ers not­ing in­creased de­mand. Michael Ganio, se­nior di­rec­tor of phar­ma­cy prac­tice and qual­i­ty at ASHP, pre­vi­ous­ly told Fo­cus via email: “We have mul­ti­ple re­ports of in­creas­es in pur­chas­es and uti­liza­tion of seda­tives like mi­da­zo­lam, fen­tanyl, and propo­fol to treat COVID-19 pa­tients who re­quire me­chan­i­cal ven­ti­la­tion.”

In FDA’s propo­fol short­age list­ing, gener­ic drug­mak­er Dr. Red­dy’s said it ex­pects to re­sup­ply in Oc­to­ber. In­for­ma­tion is still pend­ing from Sagent Phar­ma­ceu­ti­cals, Fre­se­nius Kabi and Te­va Phar­ma­ceu­ti­cals, al­though Sagent told ASHP that it has propo­fol 20 mL, 50 mL, and 100 mL vials on al­lo­ca­tion.

The FDA list­ing for Pfiz­er’s Hos­pi­ra, mean­while, says that for 1000 mg/100 mL (10 mg/mL) Sin­gle Dose/Sin­gle Pa­tient Use Glass Flip­top Vials, sup­plies will re­cov­er next month. But for two oth­er ver­sions of its propo­fol, sup­plies are not ex­pect­ed un­til Au­gust. Pfiz­er told ASHP that it has propo­fol 20 mL, 50 mL, and 100 mL vials avail­able in lim­it­ed sup­ply.

A Pfiz­er spokesper­son told Fo­cus via email: “As of to­day, Pfiz­er’s man­u­fac­tur­ing and dis­tri­b­u­tion net­work con­tin­ues to op­er­ate at high per­for­mance with no op­er­a­tional dis­rup­tions due to Covid-19. His­tor­i­cal­ly, Pfiz­er has had a mar­ket share of ap­prox­i­mate­ly 15% for Propo­fol. We re­cent­ly have ob­served an un­prece­dent­ed surge in de­mand for Propo­fol be­yond Pfiz­er’s his­tor­i­cal de­mand which is lim­it­ing our abil­i­ty to ful­ly sat­is­fy cus­tomer or­ders in the short-term. We are mak­ing every ef­fort to ad­vance the or­der­ing of ad­di­tion­al ma­te­ri­als, in­crease our pro­duc­tion, re­duce lead times and ex­pe­dite or­ders to cus­tomers, es­pe­cial­ly those in high-im­pact ar­eas.”

In ad­di­tion, the in­jectable seda­tive dexmedeto­mi­dine was list­ed by FDA on Fri­day as be­ing in short­age. San­doz said Mon­day that it’s dis­con­tin­u­ing its pro­duc­tion of the drug, which is in­di­cat­ed for the se­da­tion of ini­tial­ly in­tu­bat­ed and me­chan­i­cal­ly ven­ti­lat­ed pa­tients dur­ing treat­ment in an in­ten­sive care set­ting. But sev­er­al man­u­fac­tur­ers of dexmedeto­mi­dine said they ex­pect sup­plies to be back next month.

FDA Drug Short­ages

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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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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.

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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