Robert Davis, Merck CEO

FDA au­tho­rizes new Mer­ck Covid-19 pill de­spite sci­en­tist­s' con­cerns on its mech­a­nism of ac­tion

The FDA on Thurs­day au­tho­rized an­oth­er new pill to treat the Omi­cron vari­ant, this time from Mer­ck.

While Pfiz­er’s an­tivi­ral may prove to be more ef­fec­tive, and Mer­ck’s pill has left some sci­en­tists ques­tion­ing the dan­gers be­hind its mech­a­nism of ac­tion, mol­nupi­ravir will be an­oth­er weapon in the ar­ma­men­tar­i­um of Covid-19 treat­ments for the US in a time of need, as two mAb treat­ments from Re­gen­eron and Eli Lil­ly are no longer ef­fec­tive against Omi­cron, and as sup­plies of a third mAb from Vir/Glax­o­SmithK­line are very lim­it­ed.

Sup­plies of the Mer­ck pill will not be as lim­it­ed, as the US may have about 400,000 cours­es of Mer­ck’s pill avail­able in the next few days, and by the end of Jan­u­ary, the US gov­ern­ment ex­pects to have about 3 mil­lion cours­es of Mer­ck’s pill, which is the en­tire or­der that the US made.

The con­cern with Mer­ck’s pill is that it works by in­hibit­ing SARS-CoV-2 repli­ca­tion through vi­ral mu­ta­ge­n­e­sis, and some sci­en­tists have raised se­ri­ous reser­va­tions about that MOA.

The FDA’s An­timi­cro­bial Drugs Ad­vi­so­ry Com­mit­tee nar­row­ly vot­ed 13-10 last month in fa­vor of the pill’s ben­e­fits out­weigh­ing the risks for adults with­in 5 days of de­vel­op­ing Covid symp­toms.

“Com­mit­tee mem­bers who vot­ed ‘No’ cit­ed the fol­low­ing as rea­sons for con­clud­ing that the over­all ben­e­fit-risk ra­tio was un­fa­vor­able: 1) a high num­ber-need­ed-to-treat com­pared with place­bo, 2) un­clear ef­fi­ca­cy against the Delta vari­ant, 3) po­ten­tial to dri­ve vi­ral mu­ta­tions, and 4) mu­ta­genic­i­ty risks,” ac­cord­ing to a sum­ma­ry of the meet­ing.

Mer­ck has to pro­vide re­ports to the FDA on a month­ly ba­sis sum­ma­riz­ing any find­ings as a re­sult of its mon­i­tor­ing ac­tiv­i­ties of ge­nom­ic data­base(s) for the emer­gence of glob­al vi­ral vari­ants.

As part of Thurs­day’s au­tho­riza­tion, FDA made clear that it should be pro­vid­ed to those “for whom al­ter­na­tive COVID-19 treat­ment op­tions au­tho­rized by FDA are not ac­ces­si­ble or clin­i­cal­ly ap­pro­pri­ate,” mean­ing that if Pfiz­er’s pill is avail­able, that might be a bet­ter op­tion.

“I don’t think you would find any­one who would pre­fer the Mer­ck pill to the Pfiz­er pill, giv­en the da­ta ev­i­dent so far,” Walid Gel­lad, a pro­fes­sor of med­i­cine at the Uni­ver­si­ty of Pitts­burgh, told End­points News pre­vi­ous­ly.

As part of the EUA, the FDA said Mer­ck has to “con­duct a thor­ough in­ves­ti­ga­tion in­to the dif­fer­ences in ef­fi­ca­cy ob­served in the first and sec­ond half” of its piv­otal tri­al. Pan­elists at the ad­comm last month cen­tered their ques­tion­ing on the cause of this drop-off in pre­vent­ing hos­pi­tal­iza­tions and deaths, from 50% to 30% be­tween in­ter­im and fi­nal re­sults. Mer­ck and the FDA of­fered few specifics at the meet­ing on why the ef­fi­ca­cy de­clined.

Un­like the Pfiz­er pill, the FDA al­so warned Thurs­day that mol­nupi­ravir is not rec­om­mend­ed for use dur­ing preg­nan­cy, as based on find­ings from an­i­mal re­pro­duc­tion stud­ies, mol­nupi­ravir may cause fe­tal harm.

Mer­ck must main­tain a preg­nan­cy sur­veil­lance pro­gram to col­lect in­for­ma­tion on in­di­vid­u­als who are ex­posed to mol­nupi­ravir dur­ing preg­nan­cy. FDA al­so said that sex­u­al­ly ac­tive in­di­vid­u­als with part­ners of child­bear­ing po­ten­tial are ad­vised to use con­tra­cep­tion dur­ing mol­nupi­ravir treat­ment and for at least three months af­ter the last dose.

Mol­nupi­ravir is al­so not au­tho­rized for use in pa­tients who are less than 18 years of age, or for use for longer than 5 con­sec­u­tive days. A course of treat­ment is ad­min­is­tered as four 200 mil­ligram cap­sules tak­en oral­ly every 12 hours for five days, for a to­tal of 40 cap­sules.

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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Covid-19 roundup: Pfiz­er/BioN­Tech launch Omi­cron-spe­cif­ic vac­cine tri­al; UK to re­cruit thou­sands more for mol­nupi­ravir study

Pfizer and BioNTech announced Tuesday that they’ve initiated a clinical study to evaluate the safety, tolerability and immunogenicity of an Omicron-targeted vaccine candidate in healthy adults 18 through 55 years of age, although it remains unclear when, if ever, that vaccine might be necessary.

Drawing on some of the participants from the companies’ Phase III booster study, the trial will enroll up to 1,420 participants and evaluate three groups of healthy adults up to the age of 55, including one group who received 2 doses of the Pfizer vaccine and will get one shot of the Omicron-specific booster, one group that received three doses of the Pfizer vaccine and will get one of the Omicron-based vaccines, and then a third group receiving three doses of the Omicron-based vaccine.

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.