Ku ya 29 Kamena,Intercept Pharmaceuticals yatangajweko yakiriye imiti mishya yuzuye yatanzwe na FDA yo muri Amerika kubyerekeye 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 bitaramenyekana, kandi inyungu zo kwivuza ntizirenze ingaruka zishobora kubaho, bityo ntizibe. shyigikire byihuse OCA yo kuvura abarwayi ba NASH batera fibrosis yumwijima.

Mark Pruzanski, Perezida akaba n'Umuyobozi mukuru wa Intercept, yagize icyo avuga ku bisubizo yagize ati: “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 yiyongera buhoro buhoro ibintu bigoye byerekana amateka, bityo ikora inzitizi ndende cyane yo kunyuramo. Kugeza ubu,OCAni gusa mubyiciro bitatu byingenzi. Iki cyifuzo cyujujwe mugihe cyo kwiga. Turateganya kubonana na FDA vuba bishoboka kugira ngo tuganire ku buryo bwo kwemeza gahunda yo kwemeza amakuru ya CRL mu bihe biri imbere. ”

Mu marushanwa yo gufata ibiyobyabwenge bya NASH byashyizwe ku rutonde rwa mbere, Intercept yamye iri ku mwanya wa mbere 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 ikabije yakiriye dosiye nyinshi zaOCAMu barwayi, kimwe cya kane cy’ibimenyetso by’umwijima by’abarwayi byahinduwe neza, kandi ubuzima ntibwifashe nabi.

FDA yasabye ko Intercept itanga andi makuru y’agateganyo n’amakuru y’umutekano avuye mu bushakashatsi bwa REGENERATE kugirango ashyigikireUbushobozi bwa OCAkwihutisha kwemezwa, anerekana 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 cyagabanutse hafi 40% kuwa mbere kigera ku $ 47.25 kumugabane. Ibiciro byimigabane yandi masosiyete yimiti nayo yateje imbere NASH nayo yagabanutse. Muri bo, Madrigal yagabanutseho hafi 6%, naho Viking, Akero na GenFit bagabanutseho 1%.

Umusesenguzi wa Stifel, Derek Archila, yanditse muri raporo ku mukiriya ko kwangwa byatewe n'ingaruka ziterwa 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 umubyibuho ukabije 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 kugeza 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.