Na June 29,Intercept Pharmaceuticals ekwuputalana ọ natara ngwa ọgwụ ọhụrụ zuru oke site na US FDA gbasara FXR agonist obeticholic acid (OCA) maka fibrosis nke steatohepatitis na-abụghị mmanya kpatara (NASH) leta nzaghachi (CRL).FDA kwuru na CRL na dabere na data enyochala ugbu a, ọ kwenyere na uru a na-atụ anya na ọgwụ ahụ dabere na njedebe ikpe ikpe histopathology ọzọ ka na-ejighị n'aka, na uru nke ọgwụgwọ adịghị agafe ihe ize ndụ ndị nwere ike ime, n'ihi ya, ọ dịghị. nkwado nkwado ngwa ngwa nke OCA maka ọgwụgwọ NASH Ndị ọrịa na-akpata fibrosis imeju.

Mark Pruzanski, President na CEO nke Intercept, kwuru na ya pụta: "N'oge nyochaa usoro, na FDA mgbe ekwupụtaghị ozi na accelerating ihu ọma nke OCA, na anyị kwenyesiri ike na ihe niile data enịm ruo ugbu a izute chọrọ nke FDA na n'ụzọ doro anya na-akwado OCA mma uru ize ndụ.Anyị na-akwa ụta CRL a.FDA ejirila nwayọọ nwayọọ mụbaa mgbagwoju anya nke njedebe akụkọ ihe mere eme, si otú a na-emepụta ihe mgbochi dị elu nke ịgafe.Rute ugbu a,OCAbụ naanị na isi ụzọ atọ.Emeela ihe a chọrọ n'oge ọmụmụ ihe.Anyị na-eme atụmatụ izute FDA ozugbo enwere ike iji kparịta ka anyị ga-esi nyefee atụmatụ nkwado na ozi CRL n'ọdịnihu."

N'ọsọ iji jide ọgwụ NASH nke mbụ edepụtara, Intercept anọwo na-ebute ụzọ ma ugbu a bụ naanị ụlọ ọrụ nwetara data ikpe ikpe dị mma n'oge.Dị ka onye nwere ike na kpọmkwem farnesoid X agonist (FXR) agonist,OCAenwetala nsonaazụ dị mma na mbụ n'ime nnwale ụlọọgwụ nke 3 akpọrọ REGENERATE.Ihe omuma a gosiputara na NASH agafeghị oke ma buru oke ibu onye natara oke ogwu nkeOCAN'ime ndị ọrịa ahụ, otu ụzọ n'ụzọ anọ nke mgbaàmà imeju fibrosis imeju ndị ọrịa emeela ka ọ dịkwuo mma, ọnọdụ ahụ emebibeghị.

FDA tụrụ aro ka Intercept nyefee arụmọrụ nwa oge na data nchekwa site na ọmụmụ REGENERATE na-aga n'ihu iji kwadoIke OCAnkwado ngwa ngwa, ma rụtụ aka na nsonaazụ ogologo oge nke ọmụmụ kwesịrị ịga n'ihu.

AgbanyeghịOCAakwadoro na mbụ maka ọrịa imeju ọzọ na-adịghị ahụkebe (PBC), ubi NASH buru ibu.A na-eme atụmatụ na NASH na-emetụta ọtụtụ nde mmadụ na United States naanị.Na mbụ, ụlọ akụ itinye ego na JMP Securities mere atụmatụ na ahịa kacha elu nke ọgwụ Intercept nwere ike iru ijeri dollar.Akụkọ ọjọọ a metụtara, ọnụ ahịa ngwaahịa Intercept dara ihe fọrọ nke nta ka ọ bụrụ 40% na Mọnde ruo $47.25 kwa òkè.Ọnụ ahịa ngwaahịa nke ụlọ ọrụ ndị ọzọ na-emepụta ọgwụ na-emepụtakwa NASH adawokwa.N'ime ha, Madrigal dara ihe dịka 6%, na Viking, Akero na GenFit dara ihe dịka 1%.

Stifel analyst Derek Archila dere na akụkọ nye onye ahịa na ọjụjụ ahụ bụ n'ihi mmetụta ndị metụtara ọgwụgwọ nke mere naNlele ụlọ ọgwụ OCA, ya bụ, ụfọdụ ndị ọrịa nataraỌgwụgwọ OCA, cholesterol na-emerụ ahụ na-abawanye, nke na-eme ka ha nwee nnukwu ihe ize ndụ nke ọrịa obi.Nyere na ọtụtụ ndị ọrịa NASH enweelarị ibu ibu ma ọ bụ na-arịa ọrịa shuga 2, mmetụta dị otú ahụ nwere ike ịkpalite ịmụrụ anya nke ụlọ ọrụ nchịkwa.Dabere na ihe FDA chọrọ maka data nnwale ọzọ, Intercept nwere ike ichere ruo opekata mpe ọkara nke abụọ nke 2022 iji kọwaa data ndị a.Nyocha mpụga kwenyere na ogologo oge dị otú ahụ nwere ike ikpochapụ akụkụ nke ụzọ nnakọbara nke Intercept gara aga, na-enye ohere ka ndị asọmpi ndị ọzọ gụnyere Madrigal Pharmaceuticals na Viking Therapeutics nweta ohere iji nweta.