A ranar 29 ga watan Yuni.An sanar da Intercept Pharmaceuticalscewa ta karɓi cikakken sabon aikace-aikacen magani daga FDA ta Amurka game da FXR agonist obeticholic acid (OCA) don fibrosis wanda ba ya haifar da steatohepatitis (NASH) Response letter (CRL).FDA ta bayyana a cikin CRL cewa dangane da bayanan da aka sake dubawa ya zuwa yanzu, ta yi imanin cewa fa'idodin da ake tsammani na miyagun ƙwayoyi dangane da madadin ƙarshen gwajin maganin histopathology har yanzu ba su da tabbas, kuma fa'idodin jiyya ba su wuce haɗarin haɗari ba, don haka bai kamata ba. goyan bayan hanzarin amincewa da OCA don kula da NASH Marasa lafiya waɗanda ke haifar da fibrosis hanta.

Mark Pruzanski, Shugaba da Shugaba na Intercept, yayi sharhi game da sakamakon: "A yayin aiwatar da bita, FDA ba ta taɓa ba da bayanai game da haɓaka amincewar OCA ba, kuma mun yi imani da tabbaci cewa duk bayanan da aka ƙaddamar ya zuwa yanzu sun dace da buƙatun FDA kuma a sarari suna tallafawa haɗarin riba mai kyau na OCA.Mun yi nadama da wannan CRL.FDA a hankali ta ƙara rikiɗar wuraren ƙarshen tarihi, don haka haifar da babban shinge don wucewa.Ya zuwa yanzu,OCAyana cikin maɓalli uku kawai.An biya wannan bukata yayin binciken.Muna shirin ganawa da FDA da wuri-wuri don tattauna yadda za a zartar da tsarin amincewa kan bayanan CRL a nan gaba. "

A cikin tseren karɓar maganin NASH na farko da aka jera, Intercept koyaushe yana kan gaba kuma a halin yanzu shine kawai kamfani da ya sami ingantaccen bayanan gwaji na ƙarshen zamani.A matsayin mai ƙarfi kuma takamaiman farnesoid X agonist (FXR) agonist,OCAA baya ya sami sakamako mai kyau a cikin gwaji na asibiti na lokaci 3 da ake kira REGENERATE.Bayanai sun nuna cewa NASH matsakaita zuwa mai tsanani wadanda suka sami allurai masu yawa naOCAA cikin marasa lafiya, kashi ɗaya cikin huɗu na alamun fibrosis na hanta na marasa lafiya an inganta sosai, kuma yanayin bai taɓa yin rauni ba.

FDA ta ba da shawarar cewa Intercept ta ƙaddamar da ƙarin inganci na wucin gadi da bayanan aminci daga binciken REGENERATE mai gudana don tallafawaYiwuwar OCAhanzarta amincewa, kuma ya nuna cewa ya kamata a ci gaba da sakamakon binciken na dogon lokaci.

Ko da yakeOCAAn riga an amince da shi don wata cutar hanta da ba kasafai ba (PBC), filin NASH yana da girma.An kiyasta cewa NASH na shafar miliyoyin mutane a Amurka kadai.A baya can, bankin zuba jari JMP Securities ya kiyasta cewa kololuwar siyar da magungunan Intercept na iya kaiwa biliyoyin daloli.Wannan mummunan labari ya shafa, farashin hannun jari na Intercept ya faɗi kusan kashi 40% a ranar Litinin zuwa $47.25 a kowace rabon.Haka kuma farashin hannayen jarin wasu kamfanonin harhada magunguna da su ma suka bunkasa NASH ya fadi.Daga cikin su, Madrigal ya fadi da kusan 6%, kuma Viking, Akero da GenFit sun fadi da kusan 1%.

Wani manazarci Stifel Derek Archila ya rubuta a cikin wani rahoto ga abokin ciniki cewa kin amincewa ya kasance ne saboda illolin da ke da alaƙa da jiyya da suka faru aGwajin asibiti na OCA, wato wasu marasa lafiya sun samuOCA magani, Cholesterol mai cutarwa a cikin jiki ya karu, wanda hakan zai sa su sami ƙarin haɗarin cututtukan zuciya.Ganin cewa yawancin marasa lafiya na NASH sun riga sun yi kiba ko kuma suna fama da ciwon sukari na 2, irin wannan sakamako na iya tayar da hankali na hukumomin gudanarwa.Dangane da buƙatun FDA don ƙarin bayanan gwaji, Intercept na iya jira har sai aƙalla rabin na biyu na 2022 don fassara waɗannan bayanan.Binciken waje ya yi imanin cewa irin wannan doguwar jinkiri na iya shafe wani ɓangare na tarin gubar da aka tara a baya na Intercept, yana barin sauran masu fafatawa ciki har da Madrigal Pharmaceuticals da Viking Therapeutics su sami damar cim mawa.