Bayer Verquvo (vericiguat) te apwouve nan EWOP la, ak Lachin te antre nan revizyon an!---1/2

Bayer denyeman te anonse ke Komisyon Ewopeyen an (EC) te apwouve Verquvo (vericiguat, 2.5 mg, 5mg, 10mg tablet), ki se yon idrosolubl guanylate cyclase (sGC) stimulator pou evenman ki sot pase yo yon pasyan granmoun ak entomatik echek ke kwonik ki restaure soti nan yon evenman dekonpoze ki egzije sewom (SEWOM) terapi e li gen yon redwi ejection fraksyon. Apwobasyon Verquvo a baze sou rezilta yo nan faz enpotan 3 VICTORIA jijman an, ki espesyalman pasyan objektif ki te denyeman ki gen eksperyans gravasyon ke echek (ospitalizasyon resan pou echek ke oswa itilize nan sewom diuretics). Rezilta yo montre ke Apre yon evenman gravasyon ke echek ke, Verquvo konbine ak terapi background siyifikativman redwi risk yo konbine nan lanmo e ak venn oswa echek ke ospitalizasyon konpare ak terapi background pou kont li.

Verquvo te pran orally yon fwa pa jou, ak engredyan pharmaceutique aktif li yo vericiguat se yon premye-an-klas stimulator nan idrosolubl guanylate cyclase (sGC). Malgre ke SGC enpotan pou veso san ak fonksyon ke, nan pasyan ki gen echek ke, akoz nitrik oksid (no) disponiblite ak ensifizan sGC eksitasyon, li mennen nan myocardial ak askile malfonksyonman. Vericiguat te konjwentman devlope pa Merck ak Bayer, ak de pati yo te rive yon koperasyon mondyal nan mwa oktob 2014 yo devlope sGC regilate yo. Merck posede dwa commercialization yo nan vericiguat ozetazini, ak Bayer gen dwa eksklizif pou res mond lan.

Verquvo mekanis nan aksyon se diferan de metod tretman ki deja egziste ke. Li bay yon metod espesyal pou jere pasyan yo ak echek ke kwonik Apre yon evenman dekonpoze (tou li te ye kom yon evenman gravasyon). Metod tretman aktyel yo anpeche Efe yo danjere nan sistem nan neurohormonal natirel, ki se aktive pa malfonksyonman yo myocardial ak askile ki fet pandan echek ke. Verquvo travay nan konjonksyon ak tretman ki deja egziste nan yon mod diferan nan aksyon. Dwog la espesyalman retabli defektye a pa gen okenn-sGC-cGMP chemen, ki jwe yon wol kle nan pwogresyon nan echek ke ak nmedman nan sentom maladi.

Verquvo se premye idrosolubl guanylate cyclase (sGC) stimulator apwouve pou tretman an nan echek ke. Nan mwa Janvye nan ane sa a, Verquvo te apwouve nan Etazini pou itilize nan entomatik pasyan ki kwonik ke echek ak yon fraksyon ejection<45%, to="" reduce="" the="" occurrence="" of="" worsening="" heart="" failure="" events="" (defined="" as:="" heart="" failure="" hospitalization="" or="" receiving="" outpatient="" veins="" without="" hospitalization="" [iv]="" the="" risk="" of="" cardiovascular="" death="" and="" hospitalization="" for="" heart="" failure="" after="" diuretic="" treatment="" of="" heart="" failure.="" in="" june="" of="" this="" year,="" verquvo="" was="" approved="" in="" japan="" for="" the="" treatment="" of="" chf="" patients="" who="" are="" receiving="" standard="" treatment="" for="" chronic="" heart="" failure="" (chf)="" to="" reduce="" the="" risk="" of="" further="" worsening="" events.="" currently,="" vericiguat="" is="" also="" undergoing="" censorship="" from="" china="" and="" other="" countries.="" in="" china,="" bayer="" submitted="" a="" marketing="" authorization="" application="" for="" vericiguat="" to="" the="" national="" medical="" products="" administration="" (nmpa)="" at="" the="" end="" of="" august="">