NgoJuni 29,I-Intercept Pharmaceuticals imenyezelweukuthi ithole isicelo somuthi esisha esiphelele esivela ku-US FDA mayelana ne-FXR agonist obeticholic acid (OCA) ye-fibrosis ebangelwa i-non-alcoholic steatohepatitis (NASH) Response letter (CRL).I-FDA isho ku-CRL ukuthi ngokusekelwe kudatha ebuyekeziwe kuze kube manje, ikholelwa ukuthi izinzuzo ezilindelekile zomuthi ngokusekelwe kwezinye iziphetho zesilingo se-histopathology zisangaqiniseki, futhi izinzuzo zokwelashwa azeqi izingozi ezingaba khona, ngakho azenzi. ukusekela ukugunyazwa okusheshisiwe kwe-OCA yokwelashwa kwe-NASH Iziguli ezibangela i-liver fibrosis.

UMark Pruzanski, uMongameli kanye ne-CEO ye-Intercept, iphawule ngemiphumela: “Phakathi nenqubo yokubuyekeza, i-FDA ayikaze ikhulume ngolwazi lokusheshisa ukugunyazwa kwe-OCA, futhi sikholelwa ngokuqinile ukuthi yonke idatha ethunyelwe kuze kube manje ihlangabezana nezimfuneko ze-FDA futhi Isekela ngokusobala ingcuphe yenzuzo enhle ye-OCA.Siyazisola ngale CRL.I-FDA ikhulise kancane kancane ubunkimbinkimbi bezindawo zokugcina ze-histological, ngaleyo ndlela idale umgoqo ophezulu kakhulu wokudlula.Kwaze kwakude,OCAisezigabeni ezintathu ezibalulekile kuphela.Lesi sidingo sihlangatshezwe ngesikhathi socwaningo.Sihlela ukuhlangana ne-FDA ngokushesha okukhulu ukuze sixoxe ngokuthi singaludlulisa kanjani uhlelo lokugunyaza ngolwazi lwe-CRL esikhathini esizayo.”

Emncintiswaneni wokubamba umuthi wokuqala osohlwini lwe-NASH, i-Intercept ibihlezi isendaweni ehamba phambili futhi okwamanje iyona kuphela inkampani ethole idatha yesilingo sesigaba sakamuva esihle.Njenge-agonist enamandla futhi ethize ye-farnesoid X receptor (FXR),OCAngaphambilini uzuze imiphumela emihle esivivinyweni somtholampilo sesigaba sesi-3 esibizwa ngokuthi REGENERATE.Idatha ibonise ukuthi i-NASH emaphakathi ukuya kokuqina ethole imithamo ephezulu yeOCAPhakathi kweziguli, ingxenye eyodwa kwezine yezimpawu ze-liver fibrosis yeziguli ibe ngcono kakhulu, futhi isimo asikabi sibi.

I-FDA income ukuthi i-Intercept ilethe ukusebenza ngempumelelo kwesikhashana okwengeziwe kanye nedatha yokuphepha evela ocwaningweni oluqhubekayo lwe-REGENERATE ukuze isekele.Amandla we-OCAyasheshisa ukugunyazwa, futhi yaveza ukuthi imiphumela yesikhathi eside yocwaningo kufanele iqhubeke.

NakubaOCAiye yavunyelwa ngaphambilini ngesinye isifo sesibindi esingavamile (PBC), insimu ye-NASH inkulu.Kulinganiselwa ukuthi i-NASH ithinta izigidi zabantu e-United States kuphela.Ngaphambilini, ibhange lokutshalwa kwezimali i-JMP Securities lalilinganisela ukuthi inani eliphakeme lokuthengiswa kwezidakamizwa ze-Intercept lingafinyelela izigidigidi zamadola.Ethintwe yilezi zindaba ezimbi, intengo yesitoko se-Intercept yehle cishe ngo-40% ngoMsombuluko yaya ku-$47.25 ngesheya ngalinye.Izintengo zamasheya zezinye izinkampani ezenza imithi nazo ezithuthukise i-NASH nazo zehlile.Phakathi kwazo, iMadrigal yehle cishe ngo-6%, kwathi iViking, Akero neGenFit yehla cishe ngo-1%.

Umhlaziyi we-Stifel u-Derek Archila ubhalele iklayenti embikweni ukuthi ukwenqaba kwakungenxa yemiphumela engemihle ehlobene nokwelashwa eyenzeke ngo.Ukuhlolwa komtholampilo kwe-OCA, okungukuthi, ezinye iziguli zatholaUkwelashwa kwe-OCA, i-cholesterol eyingozi emzimbeni yanda, okubuye Kubenze babe nengozi enkulu yengozi yenhliziyo.Njengoba kunikezwe ukuthi iziguli eziningi ze-NASH sezivele zikhuluphele ngokweqile noma zihlushwa isifo sikashukela sohlobo 2, imiphumela enjalo engemihle ingase ivuse ukuqapha kwama-ejensi alawulayo.Ngokwezimfuneko ze-FDA zedatha yokuhlola eyengeziwe, i-Intercept ingase ilinde kuze kube okungenani ingxenye yesibili ka-2022 ukuze ihumushe le datha.Ukuhlaziya kwangaphandle kukholelwa ukuthi ukubambezeleka okude kangako kungase kuqede ingxenye yokuhola enqwabelene yangaphambilini ye-Intercept, kuvumele abanye abaqhudelana nabo okuhlanganisa iMadrigal Pharmaceuticals kanye neViking Therapeutics ukuthi babe nethuba lokuyifica.