Why FDA can’t dis­close the first coro­n­avirus-re­lat­ed drug short­age

Around 10 PM ET last night, the FDA said that it is aware of a drug short­age re­lat­ed to an ac­tive phar­ma­ceu­ti­cal in­gre­di­ent (API) man­u­fac­tur­er af­fect­ed by the coro­n­avirus, but the agency stopped short of re­veal­ing what drug it is.

“The short­age is due to an is­sue with man­u­fac­tur­ing of an ac­tive phar­ma­ceu­ti­cal in­gre­di­ent used in the drug. It is im­por­tant to note that there are oth­er al­ter­na­tives that can be used by pa­tients. We are work­ing with the man­u­fac­tur­er as well as oth­er man­u­fac­tur­ers to mit­i­gate the short­age. We will do every­thing pos­si­ble to mit­i­gate the short­age,” FDA Com­mis­sion­er Stephen Hahn said in a state­ment.

An FDA spokesper­son al­so con­firmed to Fo­cus that the agency can­not dis­close the drug in short­age “as it is con­fi­den­tial com­mer­cial in­for­ma­tion.”

But she al­so ex­plained why the FDA is in a dif­fi­cult po­si­tion with re­spect to such short­ages and keep­ing the pub­lic in­formed.

“While man­u­fac­tur­ers are legal­ly re­quired to re­port drug sup­ply dis­rup­tions to FDA, they are not re­quired to pro­vide the de­tailed in­for­ma­tion on their sup­ply chain that we have need­ed to mon­i­tor the drug sup­ply since the on­set of the out­break,” the spokesper­son said. “We need the co­op­er­a­tion of the drug com­pa­nies in or­der to ob­tain ac­cu­rate in­for­ma­tion as we proac­tive­ly take steps to mit­i­gate drug short­ages, and com­pa­nies will be less will­ing to pro­vide this vol­un­tary in­for­ma­tion if they can­not trust FDA not to dis­close com­mer­cial con­fi­den­tial in­for­ma­tion such as drug names, com­pa­ny names or ex­act lo­ca­tion of fa­cil­i­ties.”

Al­though it may be dif­fi­cult to as­cer­tain which drug is af­fect­ed, re­cent­ly added drug short­ages to FDA’s list in­clude Al­ler­gan’s treat­ment for com­pli­cat­ed in­tra-ab­dom­i­nal in­fec­tions, Avy­caz (cef­tazidime and avibac­tam), My­lan’s blood pres­sure drug pin­dolol 10mg (and Sun Phar­ma­ceu­ti­cal pro­vides the same drug), and Pfiz­er’s chemother­a­py flu­dara­bine phos­phate for in­jec­tion.

Al­ler­gan told Fo­cus in a state­ment: “We are ex­pe­ri­enc­ing an out of stock sit­u­a­tion for AVY­CAZ (cef­tazidime and avibac­tam) for in­jec­tion (2.5g) as we await reg­u­la­to­ry ap­proval on a new third-par­ty man­u­fac­tur­er, which will ul­ti­mate­ly al­low us to con­tin­ue our sup­ply in the U.S. This sit­u­a­tion is not re­lat­ed to any prod­uct or safe­ty is­sue. All cur­rent­ly avail­able AVY­CAZ sup­ply is un­af­fect­ed and not at risk for re­call…To be clear our re­cent drug short­age of AVY­CAZ is not re­lat­ed to the coro­n­avirus.”

The rea­son­ing be­hind My­lan and Sun’s short­ages is list­ed as “short­age of ac­tive in­gre­di­ent,” and My­lan did not re­spond to a re­quest for com­ment.

And for flu­dara­bine, the FDA list­ing says dis­con­tin­u­a­tion of the man­u­fac­ture of the drug is due to API sup­pli­er mar­ket ex­it. The cur­rent sup­ply is ex­pect­ed to be ex­haust­ed next Au­gust.

A Pfiz­er spokesper­son told Fo­cus the short­age “is com­plete­ly un­re­lat­ed and pre-dates the out­break…The ma­jor­i­ty of our fin­ished prod­uct and ac­tive phar­ma­ceu­ti­cal in­gre­di­ent are sourced from coun­tries oth­er than Chi­na. To date, we have not seen a dis­rup­tion to our sup­ply as a re­sult of the virus.”

RAPS: First pub­lished in Reg­u­la­to­ry Fo­cus™ by the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety, the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care prod­ucts. Click here for more in­for­ma­tion.

Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; 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.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

Post-hoc analy­sis: EMA's CHMP re­jects Ipsen's po­ten­tial drug for rare ge­net­ic dis­ease

The European Medicines Agency’s Committee for Medicinal Products for Human Use on Friday rejected Ipsen Pharma’s potential treatment for a rare genetic disease known as fibrodysplasia ossificans progressiva (FOP), which causes extra bone to form outside the skeleton.

The EMA said on its website that it could not draw any firm conclusions on the benefits of the French biopharma’s Sohonos (palovarotene), which selectively targets the retinoic-acid receptor gamma (RARγ), “as the applicant’s conclusion was based on a post-hoc analysis which was neither scientifically nor clinically justified and pre-specified study objectives were not met.”

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FDA ap­proves an­oth­er in­di­ca­tion for Keytru­da, this time in the ad­ju­vant NSCLC set­ting

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.

FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.