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An amince da sabon maganin zuciya na Bayer Vericiguat a China

A ranar 19 ga Mayu, 2022, Hukumar Kula da Kayayyakin Magunguna ta kasar Sin (NMPA) ta amince da aikace-aikacen tallace-tallace na Bayer's Vericiguat (2.5 MG, 5 MG, da 10 MG) a ƙarƙashin sunan alamar Verquvo™.

Ana amfani da wannan miyagun ƙwayoyi a cikin tsofaffi marasa lafiya tare da alamun cututtuka na ciwon zuciya na zuciya da kuma rage raguwar ejection (ɓangarorin fitarwa <45%) waɗanda aka tabbatar da su bayan wani abin da ya faru a kwanan nan tare da maganin jijiya, don rage haɗarin asibiti don ciwon zuciya ko gaggawa na gaggawa na diuretic.

Amincewa da Vericiguat ya dogara ne akan sakamako mai kyau daga binciken VICTORIA, wanda ya nuna cewa Vericiguat na iya kara rage haɗarin mutuwar zuciya da kuma asibiti don ciwon zuciya ta hanyar 4.2% (cikakken hadarin raguwa / 100 haƙuri-shekaru) ga marasa lafiya da zuciya. gazawar wanda ya sami raunin raunin zuciya na kwanan nan kuma sun kasance masu tsayayye akan jiyya na jijiya tare da rage juzu'in fitarwa (rashin fitarwa <45%).

A cikin Janairu 2021, An amince da Vericiguat a Amurka don maganin cututtukan zuciya na yau da kullum a cikin marasa lafiya tare da raguwar fitarwa a ƙasa da 45% bayan fuskantar mummunan yanayin rashin lafiyar zuciya.

A watan Agusta 2021, sabon aikace-aikacen magani na Vericiguat ya karɓi ta CDE kuma daga baya an haɗa shi a cikin fifikon bita da tsarin amincewa bisa dalilan "magungunan gaggawa na asibiti, sabbin magunguna da ingantattun sabbin magunguna don rigakafi da maganin manyan cututtuka da cututtukan da ba kasafai ba" .

A cikin Afrilu 2022, Jagoran 2022 AHA / ACC / HFSA don Gudanar da Rashin Ciwon Zuciya, wanda Cibiyar Nazarin Zuciya ta Amirka (ACC), Ƙungiyar Zuciya ta Amirka (AHA), da Ƙungiyar Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙarfafawa na Ƙasar Amirka (HFSA) suka bayar. Magungunan magunguna na cututtukan zuciya tare da raguwar raguwar fitarwa (HFrEF) kuma sun haɗa da Vericiguat a cikin magungunan da ake amfani da su don kula da marasa lafiya tare da HFrEF mai haɗari mai haɗari da rashin ƙarfi na zuciya dangane da daidaitaccen jiyya.

Vericiguat wani sGC ne (mai narkewa guanylate cyclase) mai motsa rai tare da tsarin labari tare da Bayer da Merck Sharp & Dohme (MSD) suka haɓaka.Yana iya shiga tsakani kai tsaye a cikin rashin aikin siginar salula da gyara hanyar NO-sGC-cGMP.

Nazarce-nazarce da na asibiti sun nuna cewa NO-soluble guanylate cyclase (sGC) -cyclic guanosine monophosphate (cGMP) hanyar siginar siginar ita ce manufa mai yuwuwar ci gaban cututtukan zuciya na zuciya da bugun zuciya.A ƙarƙashin yanayin ilimin lissafin jiki, wannan hanyar sigina ita ce hanya mai mahimmanci don sarrafa makanikai na zuciya, aikin zuciya, da aikin endothelial na jijiyoyin jini.

A ƙarƙashin yanayin pathophysiological na gazawar zuciya, ƙãra ƙumburi da rashin aiki na jijiyoyi suna rage NO bioavailability da ƙananan cGMP kira.Rashin rashi na cGMP yana haifar da dysregulation na tashin hankali na jijiyoyin jini, jijiyoyin bugun jini da sclerosis, fibrosis da hypertrophy, da ciwon zuciya da na koda microcirculatory tabarbarewa, don haka ya kara haifar da ci gaba da ciwon zuciya, ƙara yawan kumburi da kuma kara raguwa a cikin aikin zuciya da na koda.


Lokacin aikawa: Mayu-19-2022