Giovanni Caforio, Bristol Myers Squibb CEO (Pablo Martinez Monsivais/AP Images)

Amid JAK de­ba­cle, Bris­tol My­ers set­tles in for FDA's long re­view of po­ten­tial first TYK2 drug

Bris­tol My­ers Squibb has $4 bil­lion hopes for its late-stage TYK2 in­hibitor deu­cravac­i­tinib, but the FDA’s re­cent neg­a­tive re­view for the JAK in­hibitor class has damp­ened hopes some­what. Now, the agency will get its first good look at TYK2, and Bris­tol My­ers will have to wait and hold its breath.

The FDA has set a tar­get re­view date of Sept. 10, 2022, for deu­cravac­i­tinib, a po­ten­tial first-in-class oral in­hibitor for the TYK2 sig­nal­ing path­way in pso­ri­a­sis that would be a chal­lenger to the con­tro­ver­sial JAK in­hibitors, the drug­mak­er said Mon­day.

The agency will base its re­view on find­ings from the Phase III PO­E­T­YK-PSO pro­gram, which test­ed deu­cravac­i­tinib in a three-way head-to-head against Am­gen’s Ote­zla and place­bo in mod­er­ate-to-se­vere plaque pso­ri­a­sis.

In terms of PASI 75, a mea­sure of dis­ease sever­i­ty, 58.7% and 53.6% of pa­tients on deu­cravac­i­tinib achieved PASI 75 re­sponse re­spec­tive­ly, in the PO­E­T­YK-PSO-1 and PO­E­T­YK-PSO-2 stud­ies, Bris­tol My­ers said in April. Mean­while, just 12.7% and 9.4% of place­bo pa­tients and 35.1% and 40.2% of pa­tients on Ote­zla achieved the same.

Even more promis­ing for Bris­tol My­ers, deu­cravac­i­tinib main­tained its edge over Ote­zla be­tween 24 and 52 weeks of treat­ment. At the six-month check-in, 69.0% and 59.3% of pa­tients on deu­cravac­i­tinib hit PASI 75 ver­sus 38.1% and 37.8% on Ote­zla. Of those deu­cravac­i­tinib pa­tients who hit the PASI 75 mark at six months, 82.5% and 81.4% main­tained that re­sponse at the one-year check in.

Deu­cravac­i­tinib showed sim­i­lar­ly high­er rates of skin clear­ance than place­bo and Ote­zla with a slight­ly high­er rate of se­vere side ef­fects than Am­gen’s drug.

Those side ef­fects will be a key point of con­tention dur­ing the FDA’s re­view, giv­en the TYK2 path­way is part of the JAK fam­i­ly. Bris­tol My­ers says deu­cravac­i­tinib’s high de­gree of se­lec­tiv­i­ty means the drug doesn’t in­hib­it JAK1, JAK2 or JAK3, which could help the drug avoid some of that class’ se­vere side ef­fects.

In Sep­tem­ber, the FDA wrapped a post­mar­ket­ing safe­ty re­view for Pfiz­er’s Xel­janz, find­ing an in­creased risk of se­ri­ous heart-re­lat­ed events such as heart at­tack or stroke, can­cer, blood clots, and death. That un­wel­come up­date took a big hit out of not on­ly Pfiz­er but the JAK class on the whole — in­clud­ing block­buster hope­fuls like Ab­b­Vie’s Rin­voq — af­ter the FDA changed the class’ la­bel to lim­it use to cer­tain pa­tients who are not treat­ed ef­fec­tive­ly or who ex­pe­ri­ence se­vere side ef­fects with the TNF block­ers.

While deu­cravac­i­tinib’s chances ap­pear good in pso­ri­a­sis, break­ing out in­to oth­er in­di­ca­tions could prove a chal­lenge giv­en some less-than-stel­lar re­sults else­where. In Oc­to­ber, deu­cravac­i­tinib flopped a key Phase II test in ul­cer­a­tive col­i­tis, fail­ing to spur clin­i­cal re­mis­sion at three months and miss­ing key sec­ondary end­points at an in­ter­im check-in.

De­tails on the fail­ure were slim, but Bris­tol My­ers is still hold­ing out hope in this in­di­ca­tion with an­oth­er Phase II test in the works and a broad clin­i­cal pro­gram un­der­way.

Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

FDA slams Eli Lil­ly's 'mis­lead­ing' In­sta­gram ad for its type 2 di­a­betes in­jec­tion

In a first for 2022, the FDA’s Office of Prescription Drug Promotion has issued an untitled letter, which was recently sent to Eli Lilly over what the agency calls a “misleading” and “particularly concerning” Instagram ad the company posted for its type 2 diabetes drug Trulicity.

The questionable Instagram post, which has since been deleted by Lilly, failed to adequately communicate the indication and limitations of use associated with Trulicity, FDA says.

US re­stricts use of two mon­o­clon­al an­ti­bod­ies that don't work against Omi­cron

Two monoclonal antibody combos from Eli Lilly and Regeneron are no longer authorized in the US, and shipments to states have ceased because HHS said they are “highly unlikely” to work against the sweeping new variant Omicron.

The move by the FDA comes as states like Florida have become insistent that the mAbs need to be independently evaluated, although the federal Department of Health and Human Services, which has shipped hundreds of thousands of these two mAbs to states in recent weeks, did not ship any this week.

Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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