Komite y'impuguke ya FDA ishyigikiye urutonde rwibiyobyabwenge bya methadone Xinguan

Inkomoko yishyamba: yaozhi.com 3282 0

Iriburiro: ukurikije amakuru yubuvuzi aheruka, molnupiravir irashobora kugabanya gusa ibitaro cyangwa impfu 30%.

Ku ya 30 Ugushyingo, pane ya FDA yatoye 13:10 kugirango yemeze EUA isaba molnupiravir, imiti mishya ya MSD.Niba byemejwe, mugihe cyose hari imiti ya muganga, abarwayi bemejwe cyangwa virusi zanduye barashobora gukoresha imiti murugo batiriwe bajya mubitaro cyangwa kwa muganga kwivuza nk'imiti ya antibody ya monoclonal.

Molnupiravir numuti mushya wikamba ryakozwe na mosadon kubufatanye na Ridgeback biotherapy.Yabonye uruhushya rwo gukoresha byihutirwa mu Bwongereza, ariko amakuru aheruka gusohoka yerekana ko igipimo cyiza cyagabanutse cyane.

Nk’uko byatangajwe na MSD mu cyumweru gishize, ibisubizo by’ibizamini bya nyuma byerekanye ko abantu 68 bari mu itsinda rya 699 ryashyizwe mu bitaro cyangwa bapfuye, mu gihe 48 mu barwayi 709 bafata monapiravir ari bo barushijeho kwangirika, ibyo bikaba byaragabanije ibyago byo kuba mu bitaro / bapfa bava kuri 9.7% kugeza 6.8%, naho igipimo cyo kugabanya ingaruka kigera kuri 30%.Twabibutsa ko abantu 9 bapfiriye mu itsinda rya placebo na 1 gusa mu itsinda rya molnupiravir.

Nubwo bimeze bityo ariko, komite ishinzwe impuguke muri Amerika FDA yatoye 13 kuri 10 kugirango ishyigikire molnupiravir, imiti igabanya ubukana bwa methadone, ivuga ko inyungu zisumba ingaruka.FDA ntabwo itegetswe gukurikiza ibyifuzo bya komite, ariko mubisanzwe ihitamo kubikurikiza.

Mubyongeyeho, Pfizer irashaka kandi FDA icyemezo cyibiyobyabwenge gishya.Icyiciro cya III cy’ubuvuzi bwa paxlovid, imiti mishya yo mu kanwa, cyerekana ko ibyago byo gushyirwa mu bitaro cyangwa gupfa bishobora kugabanukaho 89% ku barwayi bafite ikamba rishya ryoroheje kandi rito mu minsi itatu yo kwisuzumisha, bikaba bigereranywa n’ingaruka zo kuvura yo kutabuza antibody yikamba rishya.