An­oth­er one bites the dust? FDA warns that emerg­ing Omi­cron sub­vari­ant could make Evusheld ob­so­lete

As­traZeneca’s Covid-19 pre-ex­po­sure pro­phy­lac­tic Evusheld has man­aged to re­main rel­e­vant for im­muno­com­pro­mised and oth­er pa­tients when many of its ther­a­peu­tic peers haven’t with each new Omi­cron sub­vari­ant.

But that win streak may slow­ly come to a close as the FDA told health­care providers on Mon­day that one of the emerg­ing sub­vari­ants, BA.4.6, ren­ders Evusheld al­most com­plete­ly use­less.

Na­tion­al­ly, BA.4.6 cur­rent­ly makes up about 13% of new cas­es, com­pared to just 1% of cas­es at the be­gin­ning of Ju­ly, ac­cord­ing to the CDC. But in some re­gions, like in Iowa, Mis­souri, Kansas and Ne­bras­ka, the BA.4.6 sub­vari­ant makes up more than 20% of all Covid-19 cas­es.

As­traZeneca’s spokesper­son told End­points News in a state­ment that in vit­ro da­ta con­duct­ed by an FDA lab “showed that Evusheld is un­like­ly to be ac­tive against BA.4.6, which cur­rent­ly rep­re­sents 6.2% of in­fec­tions glob­al­ly and grow­ing slow­ly; it is not ex­pect­ed to be­come a dom­i­nant strain.”

Evusheld re­mains ac­tive against the dom­i­nant vari­ant, BA.5, the spokesper­son added, not­ing that the pro­phy­lac­tic “should con­tin­ue to pro­vide pro­tec­tion to the vast ma­jor­i­ty of in­tend­ed re­cip­i­ents.”

If BA.4.6 spreads more na­tion­al­ly, and Evusheld can no longer be used, the blow would be a big one for for As­traZeneca, which saw the in­tra­mus­cu­lar in­jec­tion pull in $914 mil­lion in the first half of 2022, and an­oth­er $135 mil­lion last year.

If an­oth­er sub­vari­ant takes over or BA.5 re­mains dom­i­nant, and Evusheld holds up, the com­mer­cial mar­ket awaits as fed­er­al funds dry up. HHS pre­vi­ous­ly said that the re­main­ing fed­er­al sup­ply of Evusheld (about 750,000 cours­es of the 1.5 mil­lion or­dered re­main) could be gone by as soon as ear­ly 2023.

FDA on Mon­day al­so up­dat­ed the Evusheld fact sheet to broad­en the pa­tient pop­u­la­tion that may ben­e­fit from it, es­pe­cial­ly among peo­ple with blood can­cers re­gard­less of treat­ment sta­tus, the spokesper­son added.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

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Am­gen, years be­hind ri­vals, says PhI obe­si­ty drug shows dura­bil­i­ty signs

While NBC ran “The Biggest Loser” for 17 seasons, deemed toxic by critics for the reality show’s punishing exercise and diet upheavals, researchers in pharmaceutical labs have been attempting to create prescription drugs that induce weight loss — and one pharma betting it can require less frequent dosing is out with a new crop of data.

Amgen was relatively late to the game compared to its approved competitor Novo Nordisk and green light-approaching rival Eli Lilly. But early data suggested Amgen’s AMG 133 led to a 14.5% weight reduction in the first few months of dosing, buoying shares earlier this fall, and now the California pharma is out with its first batch of durability data showing that figure fell slightly to 11.2% about 150 days after the last dose. Amgen presented at the 20th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease on Saturday afternoon.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls



Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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US month­ly costs for biosim­i­lars 'sub­stan­tial­ly high­er' than Ger­many or Switzer­land, JA­MA re­search finds

As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.

Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.

Kirk Myers is shown in a still image from a new film series showcasing the efforts of HIV advocates funded by Gilead.

Gilead spot­lights HIV projects and the com­mu­ni­ty lead­ers dri­ving them in new mi­ni-doc­u­men­tary films

Gilead is going behind the scenes of some of the HIV initiatives it funds through grants in a new film series narrated by the people helming the projects.

The first four films and leaders come from across the US — Arianna Lint in Florida and Puerto Rico, Cleve Jones in San Francisco, June Gipson in Mississippi and Kirk Myers in Texas. Their HIV-focused efforts range from addressing unmet needs of the transgender community to delivering social services and high-quality health care in underserved communities.

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EMA pulls an opi­oid from the 1950s used to treat dry cough

The European Medicines Agency said Friday that it’s pulling from all European markets pholcodine-containing medicines, which are an opioid used in adults and children for the treatment of dry cough and in combo with other drugs as a treatment for cold and flu.

The decision to pull the medicines comes as the EMA points to the results from the recent ALPHO study, which show that use of pholcodine during the 12 months preceding anesthesia is linked to a risk of an anaphylactic reaction related to the neuromuscular blocking agents (NMBAs) used (with an adjusted OR of 4.2, and a 95% confidence interval of 2.5 to 6.9).

Bay­er starts work on $43M+ ex­pan­sion of OTC man­u­fac­tur­ing site in Penn­syl­va­nia

German pharma giant Bayer will be looking to make a significant investment into one of its US plants that produces over-the-counter drugs.

Bayer announced that it will spend $43.6 million to expand its facility in Myerstown, PA, a small town east of Harrisburg. Bayer plans to increase the site by 70,000 square feet and will have room for the installation of eight packaging lines and an area to install rooftop solar panels. The project is expected to be completed by 2025 and will add around 50 to 75 jobs.