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.

@FDACDERDi­rec­tor @Dr­Wood­cockF­DA Be­fore FDA ap­proves mol­nupi­ravir, please con­sid­er the be­low con­cerns about how its poor ef­fi­ca­cy in­di­cates vi­ral repli­ca­tion is not be­ing sup­pressed ef­fi­cient­ly, sug­gest­ing that vi­able mu­tant virus­es may be trans­mis­si­ble from pa­tients. Thank you. https://t.co/0ZFwtlHKVj

— Michael Lin, PhD-MD ? (@michael­zlin) De­cem­ber 23, 2021 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.

CALQUENCE is a registered trademark of the AstraZeneca group of companies.

At the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition, blood cancer researchers from around the world gathered virtually to discuss the progress that has been made in the field of hematology. Over the past decade, that progress has been tremendous. We’ve seen not only breakthrough approaches to care, but also significant improvement upon existing novel treatments and exploring combinations within those medicines.1 These advances have transformed expectations of what a blood cancer diagnosis now means for patients. While we’ve come a long way, I believe the most exciting scientific discovery is yet to come, and that future advances will truly transform patient care.

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