Ku ya 29 Kamena,Guhagarika imiti yatangajweko yakiriye imiti mishya itangwa na FDA yo muri Amerika yerekeranye na FXR agonist obeticholic aside (OCA) kuri fibrosis iterwa na steatohepatitis idafite inzoga (NASH) ibaruwa isubiza (CRL).FDA yavuze muri CRL ko ishingiye ku makuru yasuzumwe kugeza ubu, yizera ko inyungu ziteganijwe ku biyobyabwenge zishingiye ku bindi bisubizo by’ibizamini bya histopathology zitaramenyekana, kandi inyungu zo kwivuza ntizirenze ingaruka zishobora kubaho, bityo ntizibe. shyigikira ibyemezo byihuse bya OCA kuvura abarwayi ba NASH batera fibrosis yumwijima.

Mark Pruzanski, Perezida akaba n'Umuyobozi mukuru wa Intercept, yagize icyo avuga ku bisubizo: “Mu gihe cyo gusuzuma, FDA ntabwo yigeze itanga amakuru ku bijyanye no kwihutisha icyemezo cya OCA, kandi twizera tudashidikanya ko amakuru yose yatanzwe kugeza ubu yujuje ibisabwa na FDA kandi ashyigikira byimazeyo ingaruka za OCA.Turicuza iyi CRL.FDA yagiye yongera buhoro buhoro ibintu bigoye byamateka, bityo irema inzitizi ndende cyane kunyuramo.Kugeza ubu,OCAni gusa mubyiciro bitatu byingenzi.Iki cyifuzo cyujujwe mugihe cyo kwiga.Turateganya guhura na FDA vuba bishoboka kugira ngo tuganire ku buryo bwo gutambutsa gahunda yo kwemeza amakuru ya CRL mu bihe biri imbere. ”

Mu irushanwa ryo gufata ibiyobyabwenge bya NASH byashyizwe ku rutonde, Intercept yamye iri kumwanya wambere kandi kuri ubu niyo sosiyete yonyine yabonye amakuru meza yo kugerageza.Nkumuntu ukomeye kandi wihariye wa farnesoid X reseptor (FXR) agonist,OCAmbere yageze kubisubizo byiza mugice cya 3 cyamavuriro yiswe REGENERATE.Amakuru yerekanaga ko NASH iringaniye kandi ikaze yakiriye dosiye nyinshiOCAMu barwayi, kimwe cya kane cy’ibimenyetso bya fibrosis y’abarwayi byateye imbere ku buryo bugaragara, kandi ubuzima ntibwifashe nabi.

FDA yasabye ko Intercept itanga izindi mikorere mfatakibanza namakuru yumutekano kuva ubushakashatsi burimo gukorwa kugirango dushyigikireUbushobozi bwa OCAkwemererwa byihuse, kandi yerekanye ko ibisubizo birebire byubushakashatsi bigomba gukomeza.

NubwoOCAmbere yemerewe izindi ndwara zidasanzwe z'umwijima (PBC), umurima wa NASH ni munini.Bigereranijwe ko NASH ifata abantu babarirwa muri za miriyoni muri Amerika yonyine.Mbere, banki ishoramari JMP Securities yagereranije ko kugurisha cyane imiti ya Intercept ishobora kugera kuri miliyari y'amadorari.Kubera iyi nkuru mbi, igiciro cyimigabane ya Intercept cyaragabanutse hafi 40% kumunsi wambere kugeza $ 47.25 kumugabane.Ibiciro byimigabane yandi masosiyete yimiti nayo yateje imbere NASH nayo yagabanutse.Muri bo, Madrigal yagabanutseho 6%, naho Viking, Akero na GenFit byagabanutseho 1%.

Umusesenguzi wa Stifel, Derek Archila, yandikiye umukiriya ko raporo yanze ko ingaruka zatewe no kwivuza zabaye muriKwipimisha kwa OCA, ni ukuvuga, abarwayi bamwe bakiriweUbuvuzi bwa OCA, cholesterol yangiza mu mubiri yariyongereye, ari nako Bituma bagira ibyago byinshi byo kwandura umutima.Urebye ko abarwayi benshi ba NASH basanzwe bafite ibiro byinshi cyangwa barwaye diyabete yo mu bwoko bwa 2, ingaruka nkizo zishobora gukangurira inzego zishinzwe kugenzura.Ukurikije ibisabwa na FDA kubindi bisobanuro byikizamini, Intercept irashobora gutegereza byibuze igice cya kabiri cya 2022 kugirango isobanure aya makuru.Isesengura ryo hanze ryizera ko gutinda gutya bishobora gusibanganya igice cya mbere cya Intercept yakusanyije, bigatuma abandi bahanganye barimo Madrigal Pharmaceuticals na Viking Therapeutics bagira amahirwe yo gufata.