Isidakamizwa esisha senhliziyo sika-Bayer i-Vericiguat sigunyazwe e-China

Ngomhlaka-19 Meyi 2022, i-China's National Medical Products Administration (NMPA) yagunyaza isicelo sokumaketha se-Bayer's.I-Vericiguat(2.5 mg, 5 mg, kanye no-10 mg) ngaphansi kwegama lomkhiqizo i-Verquvo™.

Lesi sidakamizwa sisetshenziswa ezigulini ezikhulile ezinezimpawu zokuhluleka kwenhliziyo okungapheli kanye nengxenye ye-ejection encishisiwe (ingxenye ye-ejection <45%) ezinzile ngemva komcimbi wakamuva wokubola ngokwelashwa nge-intravenous, ukunciphisa ingozi yokulaliswa esibhedlela ngenxa yokwehluleka kwenhliziyo noma ukwelashwa okuphuthumayo kwe-intravenous diuretic.

Ukugunyazwa kwe-Vericiguat kwakusekelwe emiphumeleni emihle evela ocwaningweni lwe-VICTORIA, olubonise ukuthi i-Vericiguat ingaqhubeka nokunciphisa ingozi ephelele yokufa kwenhliziyo nemithambo yegazi kanye nokulaliswa esibhedlela ngenxa yokwehluleka kwenhliziyo ngo-4.2% (umcimbi wokunciphisa ngokuphelele ubungozi/iminyaka eyi-100 yesiguli) ezigulini ezinenhliziyo. ukwehluleka obekunesehlakalo sakamuva sokunciphisa ukuhluleka kwenhliziyo futhi bezinzile ekwelashweni nge-intravenous nge-fraction encishisiwe yokukhipha (ingxenye yokukhipha <45%).

NgoJanuwari 2021, i-Vericiguat yagunyazwa e-United States ukuze zelashwe izimpawu zokuhluleka kwenhliziyo okungamahlalakhona ezigulini ezinengxenyana ye-ejection engaphansi kuka-45% ngemva kokuhlangabezana nesenzakalo esiba sibi kakhulu sokuhluleka kwenhliziyo.

Ngo-Agasti 2021, isicelo esisha somuthi we-Vericiguat samukelwa yi-CDE futhi ngemva kwalokho safakwa ekubuyekezweni okubalulekile kanye nenqubo yokugunyazwa ngezizathu “zezidakamizwa eziphuthumayo, imithi emisha kanye nemithi emisha ethuthukisiwe yokuvimbela nokwelashwa kwezifo ezithathelwanayo ezinkulu kanye izifo ezingandile”.

Ngo-Ephreli 2022, i-2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure, eyakhishwa ngokuhlanganyela yi-American College of Cardiology (ACC), i-American Heart Association (AHA), kanye ne-Heart Failure Society of America (HFSA). ), ibuyekeze ukwelashwa kwe-pharmacologic yokuhluleka kwenhliziyo nge-ejection fraction encishisiwe (HFrEF) futhi yafaka i-Vericiguat emithini esetshenziselwa ukwelapha iziguli ezisengozini enkulu. I-HFrEF kanye nokukhushulwa kokwehluleka kwenhliziyo okususelwe ekwelashweni okujwayelekile.

I-Vericiguatiyisikhuthazi se-sGC (i-soluble guanylate cyclase) esinomshini wenoveli othuthukiswe ngokuhlanganyela yi-Bayer kanye ne-Merck Sharp & Dohme (MSD). Ingangenelela ngokuqondile ekuphazamisekeni kwendlela yokubonisa amaseli futhi ilungise indlela ye-NO-sGC-cGMP.

Ucwaningo lwangaphambi komtholampilo kanye nolwemitholampilo lubonise ukuthi indlela yokusayina ye-NO-soluble guanylate cyclase (sGC) -cyclic guanosine monophosphate (cGMP) iyithagethi engaba khona yokuqhubekela phambili kokuhluleka kwenhliziyo okungapheli kanye nokwelashwa kokuhluleka kwenhliziyo. Ngaphansi kwezimo zomzimba, le ndlela yokubonisa iyindlela eyinhloko yokulawula i-myocardial mechanics, umsebenzi wenhliziyo, nomsebenzi we-vascular endothelial.

Ngaphansi kwezimo ze-pathophysiological zokuhluleka kwenhliziyo, ukwanda kokuvuvukala kanye nokungasebenzi kahle kwemithambo yegazi kunciphisa i-NO bioavailability kanye ne-cGMP synthesis engezansi. Ukuntuleka kwe-cGMP kuholela ekulimazeni ukuqina kwemithambo, i-vascular and cardiac sclerosis, i-fibrosis ne-hypertrophy, kanye nokungasebenzi kahle kwe-coronary kanye ne-renal microcirculatory, ngaleyo ndlela kuholele ekulimaleni okuqhubekayo kwe-myocardial, ukuvuvukala okwandayo kanye nokwehla okuqhubekayo ekusebenzeni kwenhliziyo nezinso.


Isikhathi sokuthumela: May-30-2022