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Isingeniso: ngokwedatha yakamuva yomtholampilo, i-molnupiravir inganciphisa kuphela izinga lokulaliswa esibhedlela noma ukufa ngama-30%.
Ngomhla zingama-30 kuNovemba, ifasitelana le-FDA livotele u-13:10 ukuze ligunyaze isicelo se-EUA se-molnupiravir, umuthi omusha odluliselwa ngomlomo we-MSD.Uma kugunyazwe, inqobo nje uma kunencwadi kadokotela, iziguli eziqinisekisiwe noma abantu abavezwe yigciwane bangasebenzisa umuthi ekhaya ngaphandle kokuya esibhedlela noma emtholampilo ukuze bathole ukwelashwa okufana nemithi ye-monoclonal antibody.
I-Molnupiravir umuthi omusha okhethekile owenziwe i-mosadon ngokubambisana nenkampani ye-Ridgeback biotherapy.Ngaphambilini ithole ukugunyazwa kokusetshenziswa kwezimo eziphuthumayo e-UK, kodwa idatha yomtholampilo eshicilelwe yakamuva ibonisa ukuthi izinga elisebenzayo lehle kakhulu.
Ngokwesimemezelo se-MSD ngesonto eledlule, imiphumela yokuhlolwa yokugcina ikhombise ukuthi abantu abangama-68 eqenjini le-placebo abangama-699 balaliswe esibhedlela noma bashona, kanti zingama-48 kuphela kweziguli ezingama-709 ezithatha i-monapiravir ezibe nokuwohloka okwengeziwe, okwehlise ubungozi bokulaliswa / ukufa kusuka ku-9.7% kuya 6.8%, kanye nesilinganiso sokunciphisa ubungozi sifinyelele ku-30%.Kuhle ukusho ukuthi abantu abayi-9 bashonile eqenjini le-placebo futhi oyedwa kuphela eqenjini le-molnupiravir.
Noma kunjalo, ikomidi lochwepheshe be-FDA lase-US livotele angu-13 kuye kwayi-10 ukweseka i-molnupiravir, umuthi ongalwa namagciwane we-methadone, lathi izinzuzo zidlula ubungozi.I-FDA ayiphoqelekile ukuthi ilandele izincomo zekomiti, kodwa ngokuvamile ikhetha ukuzilandela.
Ngaphezu kwalokho, i-Pfizer iphinde ifune ukugunyazwa yi-FDA ngomuthi wayo omusha womqhele.Ucwaningo lomtholampilo lwesigaba sesi-III se-paxlovid, umuthi omusha womlomo, lubonisa ukuthi ingozi yokulaliswa esibhedlela noma yokufa ingancishiswa cishe ngama-89% ezigulini ezinomqhele omusha omnene kuya olinganiselwe phakathi kwezinsuku ezintathu zokuxilongwa, okuqhathaniswa nomphumela wokwelapha. wokunciphisa ama-antibody womqhele omusha.
Isikhathi sokuthumela: Dec-17-2021