Merck's Ridgeback Oral Antiviral Drug Molnupiravir nkag Rolling Review hauv EU: Kev Kho Mob Ntawm COVID-19!

Tsis ntev los no, Merck& Co thiab Ridgeback Biotherapeutics koom ua ke tshaj tawm tias European Medicines Agency (EMA) tau pib ua qhov kev tshuaj xyuas dov ntawmmolnupiravir ua(MK-4482/EIDD-2801), ib qho tshuaj qhov ncauj tab tom txhim kho. Cov tshuaj tiv thaiv kab mob rau kev kho mob ntawm cov neeg laus nrog COVID-19. Merck npaj yuav koom tes nrog EMA Human Medical Products Committee (CHMP) kom ua tiav cov txheej txheem tshuaj xyuas dov los pab txhawb kev pib ntawm kev tshuaj xyuas cov ntawv tso cai ua lag luam. Yog tias kev tso cai ua lag luam raug tso cai,molnupiravir uayuav dhau los ua thawj cov tshuaj tiv thaiv kab mob hauv qhov ncauj rau kev kho mob ntawm COVID-19 hauv European Union.

Nyuam qhuav pib lub hlis no, Merck tau xa daim ntawv tso cai siv thaum muaj xwm txheej ceev (EUA) daim ntawv thov rau molnupiravir mus rau US Food and Drug Administration (FDA): rau cov neeg laus uas muaj kev pheej hmoo ntawm kev mob hnyav rau COVID-19 thiab / lossis pw hauv tsev kho mob, nrog kev kho mob me me. Mob hnyav mus rau nruab nrab COVID-19. Lub tuam txhab nquag xa cov ntawv thov mus rau lwm lub koom haum tswj hwm thoob ntiaj teb.

Molnupiravir yog ib qho tshuaj tiv thaiv kab mob hauv qhov ncauj, tam sim no tau koom ua ke tsim los ntawm Merck thiab Ridgeback Biotherapeutics, thiab ob tog tau koom tes nrog cov koom haum tswj hwm thoob ntiaj teb.

Dr. Dean Y.Li, Tus Lwm Thawj Coj Thawj Coj thiab Thawj Tswj Hwm ntawm Merck Research Laboratories, tau hais tias:" Daim ntawv thov xa mus rau EMA yog lwm kauj ruam hauv peb txoj kev siv zog los txhawb molnupiravir rau cov neeg mob thoob ntiaj teb. Peb ntseeg tias molnupiravir yuav yog cov kev noj qab haus huv rau pej xeem tawm tsam COVID-19. Ib qho tseem ceeb ntxiv rau cov cuab yeej, suav nrog cov tshuaj tiv thaiv tsim los ntawm kev lag luam kws tshuaj, cov tshuaj tiv thaiv no tseem yog ib qho tseem ceeb thiab thawj kab ntawm kev tiv thaiv tus kab mob no."

Kev tswj hwm kev siv ntawmmolnupiravir uayog ua raws li cov txiaj ntsig zoo ntawm qhov kev ntsuam xyuas ib ntus ntawm Theem 3 MOVe-OUT kev sim tshuaj. Qhov kev sim tau ua rau cov neeg laus laus uas muaj mob me mus rau nruab nrab COVID-19, muaj kev pheej hmoo ntawm kev tsim mob hnyav rau COVID-19, thiab / lossis kev mus pw hauv tsev kho mob, txhawm rau ntsuas qhov ua tau zoo thiab kev nyab xeeb ntawm molnupiravir.

Kev soj ntsuam ib ntus tau pom tias piv nrog cov placebo, kev kho mob molnupiravir txo qhov kev pheej hmoo ntawm kev mus pw hauv tsev kho mob lossis kev tuag los ntawm kwv yees li 50%. Hauv pab pawg kho mob molnupiravir, 7.3% ntawm cov neeg mob tau mus pw hauv tsev kho mob lossis tuag hauv 29 hnub tom qab randomization (28/385), piv nrog 14.1% (53/377) hauv pawg placebo, thiab qhov sib txawv yog qhov tseem ceeb (p=0.0012). ). Txog hnub 29, tsis muaj neeg tuag nyob hauv pab pawg kho mob molnupiravir, thaum muaj 8 tus neeg tuag hauv pawg placebo.

Hais txog kev nyab xeeb, qhov tshwm sim ntawm cov xwm txheej tsis zoo hauv pab pawg kho mob molnupiravir thiab cov pab pawg placebo tau sib piv (35% thiab 40%, feem). Qhov tshwm sim ntawm cov xwm txheej tsis zoo cuam tshuam txog kev siv yeeb tshuaj kuj yog sib piv (12% thiab 11%, feem); piv nrog cov placebo pab pawg, tsawg dua cov neeg mob hauv covmolnupiravir uapab pawg kho mob txiav tawm kev kho mob vim muaj xwm txheej tsis zoo (1.3% thiab 3.4%, feem).

Molnupiravir yog ib lub zog hais lus ribonucleoside analog uas tuaj yeem cuam tshuam kev rov ua dua ntawm ntau yam kab mob RNA, suav nrog tus kabmob tshiab (SARS-CoV-2), uas yog cov kab mob uas ua rau COVID-19.molnupiravir uatau pom tias muaj kev ua haujlwm nyob rau hauv ntau yam qauv ua ntej ntawm SARS-CoV-2, suav nrog rau kev tiv thaiv, kev kho mob, thiab kev tiv thaiv kev sib kis, thiab tseem tau qhia txog kev ua haujlwm hauv preclinical qauv ntawm SARS-CoV-1 thiab MERS.

MOVe-OUT (MK-4482-002; NCT04575597) yog lub ntiaj teb theem 2/3, randomized, placebo-tswj, ob-dig muag, ntau qhov chaw kawm. Cov ntsiab lus tau suav nrog hauv kev sim kuaj pom tseeb tias mob me mus rau nruab nrab COVID-19 cov neeg laus tsis nyob hauv tsev kho mob (hnub nyoog ≥18 xyoo) uas tsis tau txhaj tshuaj tiv thaiv kab mob SARS-CoV-2, muaj tsawg kawg yog ib qho kev pheej hmoo cuam tshuam txog kev mob tshwm sim, thiab tsim cov tsos mob hauv 5 hnub ua ntej randomization.

Cov theem 3 ntawm qhov kev sim tau ua tiav thoob ntiaj teb, thiab cov neeg mob tau muab faib ua 2 pawg ntawm qhov sib piv 1: 1, ob zaug ib hnub, qhov ncauj molnupiravir (800mg) lossis placebo rau 5 hnub. Lub hom phiaj tseem ceeb ntawm kev ua tau zoo yog los ntsuas qhov ua tau zoo ntawmmolnupiravir uathiab cov placebo los ntawm feem pua ​​​​ntawm cov neeg mob uas tau mus pw hauv tsev kho mob thiab / lossis tuag los ntawm randomization rau hnub 29.

Hauv kev sim, feem ntau cov kev pheej hmoo pheej hmoo rau qhov tsis zoo ntawm tus kab mob suav nrog kev rog rog, hnub nyoog siab tshaj (> 60 xyoo), ntshav qab zib, thiab kab mob plawv. Delta, Gamma, thiab Mu variants suav txog ze li ntawm 80% ntawm tus kab mob hauv paus kab mob sib txawv raws li kev soj ntsuam ib ntus. Tus naj npawb ntawm cov neeg mob nrhiav neeg nyob hauv Latin America, Europe, thiab Africa suav txog 56%, 23%, thiab 15% ntawm cov neeg kawm, raws li.