Kwamitin kwararru na FDA yana goyan bayan lissafin methadone Xinguan magungunan baka

Tushen daji: yaozhi.com 3282 0

Gabatarwa: bisa ga sabbin bayanan asibiti, molnupiravir na iya rage yawan adadin asibiti ko mace-mace da kashi 30%.

A ranar 30 ga Nuwamba, kwamitin FDA ya zaɓi 13:10 don amincewa da aikace-aikacen EUA na molnupiravir, sabon maganin baka na MSD.Idan an amince da shi, muddin akwai takardar sayan magani, waɗanda aka tabbatar da marasa lafiya ko masu cutar da aka fallasa za su iya amfani da maganin a gida ba tare da zuwa asibiti ko asibiti don magani kamar magungunan rigakafin mutum ɗaya ba.

Molnupiravir sabon magani ne na musamman wanda mosadon ya haɓaka tare da haɗin gwiwar kamfanin Ridgeback biotherapy.A baya ya sami izinin amfani da gaggawa a Burtaniya, amma sabbin bayanan asibiti da aka buga sun nuna cewa ƙimar tasiri ya ragu sosai.

A cewar sanarwar MSD a makon da ya gabata, sakamakon gwajin karshe ya nuna cewa mutane 68 a cikin rukunin placebo 699 suna kwance a asibiti ko kuma sun mutu, yayin da 48 kawai daga cikin 709 marasa lafiya da ke shan monapiravir sun kara tabarbarewa, wanda ya rage hadarin asibiti / mutuwa daga kashi 9.7% zuwa 6.8%, kuma alaƙar raguwar haɗarin dangi ya kai 30%.Ya kamata a ambata cewa mutane 9 sun mutu a cikin rukunin placebo kuma 1 kawai a cikin rukunin molnupiravir.

Koyaya, kwamitin ƙwararrun FDA na Amurka ya zaɓi 13 zuwa 10 don tallafawa molnupiravir, maganin rigakafin ƙwayar cuta na methadone, yana mai cewa fa'idodin ya zarce haɗarin.FDA ba ta wajabta bin shawarwarin kwamitin, amma yawanci yakan zaɓi ya bi su.

Bugu da kari, Pfizer kuma yana neman izinin FDA don sabon maganin kambi.Nazarin asibiti na kashi na III na paxlovid, sabon maganin kambi na baka, ya nuna cewa haɗarin asibiti ko mutuwa na iya raguwa da kusan 89% a cikin marasa lafiya da sabon kambi mai sauƙi zuwa matsakaici a cikin kwanaki uku na ganewar asali, wanda yayi daidai da tasirin warkewa. na neutralizing antibody sabon kambi.


Lokacin aikawa: Dec-17-2021