Aim­mune wins ap­proval for peanut im­munother­a­py, charges 10k+

The FDA has ap­proved the first treat­ment for peanut al­ler­gy, al­though it comes with some con­tro­ver­sy.

Un­like most of the con­tro­ver­sial drugs that come be­fore the FDA, the bulk of ques­tions don’t cen­ter around this drug’s ef­fec­tive­ness or side ef­fects.

Pal­forzia, de­vel­oped by Aim­mune, has been shown to pre­vent the most se­vere re­ac­tions from ex­po­sure to small amounts of peanuts. In a Phase III tri­al, chil­dren giv­en es­ca­lat­ing dos­es of the drug were then giv­en 600 mg peanut pro­tein — about 2 peanuts — had a 67% chance of avoid­ing a se­vere re­ac­tion. For the place­bo pa­tients, the fig­ure was 4%.

Jayson Dal­las Aim­mune

“The goal — step 1 in terms of ther­a­py — is to be able to treat a child to the point you can say, if that child goes in­to the com­mu­ni­ty and ac­ci­den­tal­ly gets ex­posed to a peanut some­where, they’re not go­ing to have a life-threat­en­ing event,” Aim­mune CEO Jayson Dal­las told End­points News in an in­ter­view at the JP Mor­gan con­fer­ence ear­li­er this month.

“They may have a no re­ac­tion at all, they may have a lit­tle tin­gling, but they’re not go­ing to be at risk.”

The FDA ad­vi­so­ry com­mit­tee point­ed out that this wasn’t ide­al — you can’t eat a peanut but­ter sand­wich and a sig­nif­i­cant num­ber of the pa­tients couldn’t even eat the 2 peanuts  — and not­ed the ad­verse re­ac­tions some had to the pill. But large­ly, they agreed it was a sub­stan­tial step for­ward for a con­di­tion that has seen vir­tu­al­ly no in­no­va­tion.

Crit­ics, though, have point­ed to what’s in the drug: peanuts. Pal­forzia is a form of im­munother­a­py, by which pro­longed ex­po­sure to an al­ler­gen — in this case, peanut pow­der, most­ly but not en­tire­ly equiv­a­lent to what you can find on a su­per­mar­ket shelf — is used to build up re­sis­tance. Some doc­tors have long done this with­out any pre­scribed drug and to some suc­cess. In a 2018 study, re­searchers start­ed 270 pa­tients on 1/2,500th of a peanut and worked 80% of them up to 12 peanuts.

Pal­forzia, op­po­nents say, would take this off-la­bel treat­ment and charge thou­sands of dol­lars for it. An­a­lysts had pro­ject­ed a lit­tle over $4,000 for the price and over $1 bil­lion in peak sales. The ac­tu­al an­nu­al price, Aim­mune an­nounced to­day, will be $10,680.

The In­sti­tute for Clin­i­cal and Eco­nom­ic Re­view al­so point­ed to some of the ad­verse ef­fects pa­tients ex­pe­ri­enced from re­ceiv­ing the drug, and said the long-term ben­e­fit wasn’t clear enough to jus­ti­fy the cost and those ad­verse ef­fects.

Aim­mune has said those risks are to be ex­pect­ed when ex­pos­ing pa­tients to an al­ler­gen. They ar­gued that while doc­tors can pre­scribe pa­tients off-la­bel peanut pow­der, they are ex­posed to law­suits for any re­ac­tion a kid could have to the pow­der. By bring­ing the drug in­to the med­ical sys­tem, they say they give an op­tion for doc­tors to pre­scribe pa­tients with­out mak­ing them­selves li­able.

The drug is ap­proved for chil­dren ages 4 to 17. Aim­mune said they plan to hold pre­sen­ta­tions and work­shops to train 1,300 al­ler­gists on how to ad­min­is­ter the drug.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

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.

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.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

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.

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.