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A kwadoro ọgwụ obi ọhụrụ nke Bayer Vericiguat na China

Na Mee 19, 2022, Ụlọ Ọrụ Na-ahụ Maka Ọgwụ Ahụike Mba nke China (NMPA) kwadoro ngwa ahịa maka Bayer's Vericiguat (2.5 mg, 5 mg, na 10 mg) n'okpuru aha aha Verquvo™.

A na-eji ọgwụ a eme ihe na ndị okenye na-arịa ọrịa obi na-adịghị ala ala nke nwere mgbaàmà na-adịghị ala ala na mbelata ejection fraction (ejection fraction <45%) bụ ndị kwụsiri ike mgbe ihe omume decompensation na-adịbeghị anya na ọgwụgwọ intravenous, iji belata ihe ize ndụ nke ụlọ ọgwụ maka nkụda obi obi ma ọ bụ ọgwụgwọ diuretic intravenous mberede.

Nkwenye nke Vericiguat dabere na nsonaazụ dị mma sitere na nchọpụta VICTORIA, nke gosipụtara na Vericiguat nwere ike belata ihe ize ndụ zuru oke nke ọnwụ obi na ụlọ ọgwụ maka nkụda obi site na 4.2% (ihe omume zuru oke mbelata / 100 ndidi afọ) maka ndị ọrịa nwere obi obi. ọdịda onye nwere ihe omume nbipu obi na-adịbeghị anya ma kwụsie ike na ọgwụgwọ intravenous yana mbelata ejection ejection fraction ( ejection fraction <45%).

N'ọnwa Jenụwarị 2021, A kwadoro Vericiguat na United States maka ọgwụgwọ mgbaàmà nke ọrịa obi na-adịghị ala ala na ndị ọrịa nwere obere mpụ n'okpuru 45% mgbe ha nwesịrị ihe omume obi mgbawa na-akawanye njọ.

N'August 2021, CDE nabatara ngwa ọgwụ ọhụrụ maka Vericiguat ma mesịa tinye ya na nyocha mbụ na usoro nkwenye n'ihi "ọgwụ ahụike ngwa ngwa, ọgwụ ọhụrụ na ọgwụ ọhụrụ emelitere maka mgbochi na ọgwụgwọ nke ọrịa ndị na-efe efe na ọrịa ndị na-adịghị ahụkebe" .

N'April 2022, Ntuziaka 2022 AHA / ACC / HFSA maka njikwa nke nkụda obi, nke American College of Cardiology (ACC), American Heart Association (AHA), na Heart Failure Society of America (HFSA) nyere aka, emelitere. ọgwụgwọ pharmacologic nke nkụda obi nke nwere mbelata ejection (HFrEF) wee tinye Vericiguat n'ime ọgwụ ndị a na-eji maka ọgwụgwọ ndị ọrịa nwere nnukwu ihe egwu HFrEF na nkụda mmụọ obi dabere na usoro ọgwụgwọ.

Vericiguat bụ ihe mkpali sGC (soluble guanylate cyclase) nke nwere usoro akwụkwọ akụkọ nke Bayer na Merck Sharp & Dohme (MSD) mekọtara ọnụ.Ọ nwere ike itinye aka ozugbo na nsogbu usoro nrịbama cell ma rụkwaa ụzọ NO-sGC-cGMP.

Ọmụmụ ihe ọmụmụ na ụlọ ọgwụ egosila na NO-soluble guanylate cyclase (sGC) -cyclic gunosine monophosphate (cGMP) ụzọ akara bụ ihe nwere ike ime maka ọganihu obi mgbawa na-adịghị ala ala na ọgwụgwọ nkụda obi.N'okpuru ọnọdụ physiological, ụzọ mgbaàmà a bụ isi ụzọ nchịkwa maka usoro myocardial, ọrụ obi, na ọrụ endothelial vaskụla.

N'okpuru ọnọdụ pathophysiological nke nkụda obi, mmụba na-arịwanye elu na arụ ọrụ vaskụla na-ebelata NO bioavailability na mgbada cGMP njikọ.Enweghi ike cGMP na-eduga na dysregulation nke esemokwu vaskụla, vaskụla vaskụla na obi sclerosis, fibrosis na hypertrophy, na ọrịa akwara na akwara microcirculatory dysfunction, si otú ahụ na-eduga n'ihu na-enwe mmerụ ahụ myocardial na-aga n'ihu, mmụba na-arịwanye elu ma na-ebelata ọrụ obi na akụrụ.


Oge nzipu: Mee-19-2022