J&J and Sanofi's mul­ti­ple myelo­ma tit-for-tat con­tin­ues, as sub­cu­ta­neous Darza­lex wins com­bo ap­proval

J&J and Sanofi have gone back and forth in their mul­ti­ple myelo­ma tug-of-war. Ear­li­er this year, Sanofi notched an ap­proval of Sar­clisa in com­bi­na­tion with Am­gen’s Kypro­lis to try to out­flank the big con­glom­er­ate, but J&J is clap­ping back.

Wednes­day af­ter­noon, Am­gen an­nounced that the sub­cu­ta­neous ver­sion of J&J’s block­buster Darza­lex is al­so now ap­proved as a com­bo with Kypro­lis and dex­am­etha­sone. The green light came through for adults with re­lapsed or re­frac­to­ry mul­ti­ple myelo­ma who had pro­gressed on one to three ear­li­er lines of ther­a­py.

Am­gen ex­ecs praised the de­ci­sion, with R&D chief David Reese say­ing in a state­ment the al­ter­na­tive Darza­lex ad­min­is­tra­tion “will of­fer in­creased flex­i­bil­i­ty and con­ve­nience for pa­tients.”

The FDA de­ci­sion comes af­ter the IV for­mu­la­tion of Darza­lex ini­tial­ly clinched ap­proval with Kypro­lis back in Au­gust 2020. That OK came as Sar­clisa had just won an ap­proval the pre­ced­ing March in third-line mul­ti­ple myelo­ma pa­tients.

Though Sar­clisa has a long way to go to eclipse Darza­lex on the mar­ket, it man­aged to se­cure the same Kypro­lis com­bo green light in April 2021 — Sar­clisa plus Kypro­lis plus dex­am­etha­sone in pa­tients who pro­gressed on one to three treat­ments. The back-and-forth be­tween the two drugs will like­ly con­tin­ue as Sanofi looks to carve out more of the mar­ket.

Should it prove suc­cess­ful, there’s quite a slice of pie to be had. The IV form of Darza­lex ini­tial­ly launched in 2015 and quick­ly be­came one of J&J’s top sell­ers with $1.4 bil­lion in sales its first year. And in 2020, the drug tal­lied its best sales year yet with $4.2 bil­lion.

J&J re­ports sales to­geth­er for both forms of the drug — the IV form and the sub­cu­ta­neous ver­sion dubbed Darza­lex Faspro.

Sar­clisa has not seen as sharp an up­take, as the drug was first ap­proved about a week and a half be­fore the WHO de­clared a glob­al pan­dem­ic last year, lim­it­ing pa­tient ac­cess. Nonethe­less, it marked a mile­stone for Sanofi, be­com­ing the com­pa­ny’s first in-house can­cer ap­proval since 2010.

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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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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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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UP­DAT­ED: 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.

Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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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.

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.