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.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Hervé Affagard, MaaT Pharma CEO

One year in­to clin­i­cal hold, FDA has more ques­tions about 'pooled' mi­cro­bio­me ther­a­py

The FDA is still wary about a trial testing a microbiome therapy in patients with steroid-resistant acute graft-versus-host disease (aGVHD).

A year after MaaT Pharma’s IND application in the US was first met with a clinical hold, the French biotech said the agency is maintaining the hold. The crux of the matter, MaaT suggested, has to do with the way it puts together its drug candidate, which is administered as an enema (i.e. an injection of fluid into the bowel).

Who are the women blaz­ing trails in bio­phar­ma R&D? Nom­i­nate them for End­points' 2022 spe­cial re­port

Over the past three years, Endpoints News has spotlighted 60 women who have blazed trails and supercharged R&D across the biopharma world. And judging from the response we’ve received, to both our special reports and live events, telling their stories — including any obstacles they may have had to overcome — has inspired our readers in many different ways.

But change takes time, and the fact remains that women are still underrepresented at the upper ranks of the drug-making world.

Up­dat­ed: Amid mas­sive re­struc­tur­ing, Bio­gen looks to re­duce phys­i­cal pres­ence in Boston

Biogen is putting a sizable chunk of office and research space in Kendall Square and Weston, MA up for sublease, marking another big change as the biotech grapples with the aftershock of a disastrous and controversial rollout for its Alzheimer’s drug.

The subbleases are “part of Biogen’s overall implementation of the ‘Future of Work,’ which is allowing us to optimize our footprint and reduce the amount of space we occupy, taking into consideration new elements such as the hybrid work model,” Biogen spokesperson Ashleigh Koss wrote in a statement to Endpoints News, adding that the company has had subleases across several buildings for years.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,500+ biopharma pros reading Endpoints daily — and it's free.

Robert Califf, FDA commissioner (Tom Williams/CQ Roll Call via AP Images)

Hop­ing to ex­pand mon­key­pox vac­cine sup­ply, US paves the way for new route of ad­min­is­tra­tion

After making it clear that the US’ current monkeypox vaccine supply is insufficient, the FDA on Tuesday authorized a new route of administration that should increase the number of available doses by five-fold.

Regulators cleared Bavarian Nordic’s Jynneos vaccine for intradermal injection in adults older than 18. Unlike subcutaneous injection — the current method by which vaccine is delivered under the skin — an intradermal jab goes directly into the skin. It’s believed that this method requires less vaccine, since the dermis is rich in dendritic cells which specialize in taking up foreign antigens and presenting them to the immune system, according to Daniel Kuritzkes, chief of infectious diseases at Brigham and Women’s Hospital in Boston.

Andy Jassy, Amazon CEO (Isaac Brekken/AP Images for NFL, File)

Up­dat­ed: FDA slaps Ama­zon with a warn­ing let­ter for sell­ing OTC mole re­moval prod­ucts

The FDA’s Center for Drug Evaluation and Research on Tuesday released a warning letter sent last week to Amazon CEO Andy Jassy in Seattle for selling mole removal products over-the-counter, or, as the FDA explains, “introducing, delivering, or causing the introduction or delivery into interstate commerce of products that are unapproved new drugs.”

“There are no over-the-counter (OTC) drugs that can be legally sold for mole or skin tag removal, and FDA has safety concerns about drugs marketed OTC directly to consumers for these uses,” the agency said in its Aug. 4 warning.

Pfiz­er launch­es re­bate pro­gram for rare dis­ease pa­tients who have to stop tak­ing Panzy­ga

Pfizer is launching its second-ever rebate program, this time for Panzyga, its treatment for a rare neurological disease of the peripheral nerves.

The program began last month, according to STAT which first reported the news, and offers a refund of out-of-pocket costs for patients who must discontinue their course before the fifth treatment for “clinical reasons.”

Panzyga was approved back in 2018 to treat primary immunodeficiency (PI) in patients two years and older and chronic immune thrombocytopenia (cITP) in adults. It has since picked up an indication in chronic inflammatory demyelinating polyneuropathy (CIDP), a condition that’s characterized by weakness of the arms or legs, tingling or numbness, and a loss of deep tendon reflexes, according to the NIH.

Horizon's back-to-school campaign for children with cystinosis includes an all about me poster as part of a care package box.

Hori­zon read­ies kids and fam­i­lies for back to school with week­long ac­tiv­i­ties around rare dis­ease cysti­nosis

Going back to school is usually a bumpy readjustment from summer freedom for all kids, but especially for kids with chronic health conditions. Horizon Therapeutics is hoping to help smooth the way for some who have the rare disease cystinosis. Cystinosis is a genetic disease that causes the amino acid cystine to build up in different tissues and organs.

The “Gear Up” for school campaign is running all week with different online and at-home events and activities for families and children with cystinosis. Each family who signed up receives a care package mailed to their home including an activity coloring book “Michael’s Show-and-Tell.” The book tells Michael’s story about living with cystinosis while offering kids matching, coloring and finding object games along with information.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,500+ biopharma pros reading Endpoints daily — and it's free.

Alessandro Maselli, Catalent CEO

Catal­ent ac­quires North Car­oli­na CD­MO for $475M, boost­ing oral solids work

As Catalent has been expanding its reach in the US this year, as well as recently completing a C-suite shuffle, the company announced last night that it has acquired the CDMO Metrics Contract Services for $475 million from Mayne Pharma Group.

The acquisition will increase Catalent’s capabilities in oral solid formulation development, manufacturing and packaging as well as expand its capacity to handle more highly potent compounds.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,500+ biopharma pros reading Endpoints daily — and it's free.