Ka la 29 Phuptjane,Intercept Pharmaceuticals e phatlalalitsehore e fumane kopo e ncha e feletseng ea lithethefatsi ho tsoa ho US FDA mabapi le FXR agonist obeticholic acid (OCA) bakeng sa fibrosis e bakoang ke non-alcoholic steatohepatitis (NASH) Response letter (CRL).FDA e boletse ho CRL hore ho ipapisitsoe le lintlha tse hlahlobiloeng ho fihlela joale, e lumela hore melemo e lebelletsoeng ea moriana e thehiloeng ho liteko tse ling tsa histopathology e ntse e sa tsejoe, 'me melemo ea kalafo ha e fete likotsi tse ka bang teng, ka hona ts'ehetsa tumello e potlakileng ea OCA bakeng sa kalafo ea bakuli ba NASH ba bakang fibrosis ea sebete.

Mark Pruzanski, Mopresidente le CEO oa Intercept, o ile a bua ka liphello: "Nakong ea ts'ebetso ea tlhahlobo, FDA ha e e-s'o fane ka boitsebiso bo mabapi le ho potlakisa tumello ea OCA, 'me re lumela ka tieo hore lintlha tsohle tse rometsoeng ho fihlela joale li finyella litlhoko tsa FDA le ho tšehetsa ka ho hlaka kotsi e ntle ea phaello ea OCA.Re ikoahlaela CRL ena.FDA e ekelitse butle-butle ho rarahana ha li-endpoints tsa histological, ka hona ho theha mokoallo o phahameng haholo oa ho feta.Hole haholo,OCAe ka mekhahlelo e meraro feela ea bohlokoa.Tlhokahalo ena e fihletsoe nakong ea boithuto.Re rera ho kopana le FDA kapele kamoo ho ka khonehang ho buisana ka mokhoa oa ho fetisa leano la tumello mabapi le tlhahisoleseling ea CRL nakong e tlang. ”

Peisong ea ho inkela sethethefatsi sa pele se thathamisitsoeng sa NASH, Intercept esale e le maemong a etelletseng pele 'me hajoale ke eona feela k'hamphani e fumaneng lintlha tse ntle tsa liteko tsa morao-rao.E le agonist e matla le e khethehileng ea farnesoid X receptor (FXR),OCAe kile ea fumana litholoana tse ntle tekong ea bongaka ea mohato oa 3 e bitsoang REGENERATE.Lintlha li bontšitse hore NASH e itekanetseng ho isa ho e matla ea ileng a fumana litekanyetso tse phahameng tsaOCAHar'a bakuli, kotara ea matšoao a sebete a bakuli a ntlafalitsoe haholo, 'me boemo bona ha boa senyeha.

FDA e khothalelitse hore Intercept e fane ka lintlha tse eketsehileng tsa ts'ebetso ea nakoana le polokeho ho tsoa boithutong bo tsoelang pele ba REGENERATE ho tšehetsaMonyetla oa OCAho potlakisa tumello, mme a supa hore liphetho tsa nako e telele tsa thuto li lokela ho tsoela pele.

Leha ho le joaloOCAe kile ea amoheloa bakeng sa lefu le leng le sa tloaelehang la sebete (PBC), tšimo ea NASH e kholo.Ho hakanngoa hore NASH e ama batho ba limilione United States feela.Pejana, banka ea matsete ea JMP Securities e hakantse hore thekiso ea tlhoro ea lithethefatsi tsa Intercept e ka fihla libilione tsa lidolara.E anngoe ke litaba tsena tse mpe, theko ea setoko sa Intercept e theohile hoo e ka bang 40% ka Mantaha ho ea ho $ 47.25 ka kakaretso.Litheko tsa lihlahisoa tsa lik'hamphani tse ling tsa meriana tse ileng tsa hlahisa NASH le tsona li oele.Har'a bona, Madrigal e theohile ka hoo e ka bang 6%, 'me Viking, Akero le GenFit li theohile ka hoo e ka bang 1%.

Setsebi sa Stifel Derek Archila o ngotse tlalehong e eang ho moreki hore ho hana ho ne ho bakoa ke litlamorao tse amanang le kalafo tse etsahetsengTlhahlobo ea kliniki ea OCA, ke hore, bakuli ba bang ba ile ba amohelaPhekolo ea OCA, k'holeseterole e kotsi 'meleng e ile ea eketseha, e leng se etsang hore ba be le kotsi e kholo ea kotsi ea pelo.Kaha bakuli ba bangata ba NASH ba se ba le boima bo feteletseng kapa ba tšoeroe ke lefu la tsoekere la mofuta oa 2, litla-morao tse joalo li ka tsosa ho falimeha ha mekhatlo ea taolo.Ho latela litlhoko tsa FDA bakeng sa tlhaiso-leseling e eketsehileng ea liteko, Intercept e kanna ea tlameha ho ema ho fihlela bonyane halofo ea bobeli ea 2022 ho fetolela lintlha tsena.Litlhahlobo tsa kantle li lumela hore tieho e telele joalo e ka hlakola karolo ea karolo ea pele e bokelletsoeng ea Intercept, ea lumella bahlolisani ba bang ho kenyelletsa Madrigal Pharmaceuticals le Viking Therapeutics ho ba le monyetla oa ho fumana.