Pa Juni 29,Intercept Pharmaceuticals adalengezakuti yalandira ntchito yatsopano yamankhwala kuchokera ku US FDA yokhudzana ndi FXR agonist obeticholic acid (OCA) ya fibrosis yoyambitsidwa ndi kalata yoyankha yopanda mowa ya steatohepatitis (NASH) (CRL).A FDA adanena mu CRL kuti kutengera zomwe zawunikiridwa mpaka pano, akukhulupirira kuti mapindu omwe akuyembekezeredwa a mankhwalawa potengera zotsatira za mayeso ena a histopathology akadali osatsimikizika, ndipo mapindu a chithandizo samapitilira zoopsa zomwe zingachitike, chifukwa chake sizingachitike. Thandizo limathandizira kuvomerezedwa kwa OCA pochiza Odwala a NASH omwe amayambitsa chiwindi fibrosis.

Mark Pruzanski, Purezidenti ndi CEO wa Intercept, ndemanga pa zotsatira: "Panthawi yowunikiranso, a FDA sanalankhulepo zambiri za kufulumizitsa kuvomereza kwa OCA, ndipo tikukhulupirira kuti zonse zomwe zaperekedwa mpaka pano zikukwaniritsa zofunikira za FDA ndipo momveka bwino Kuthandizira kuopsa kwa phindu la OCA.Timadandaula ndi CRL iyi.A FDA awonjezera pang'onopang'ono zovuta za mapeto a histological, motero amapanga chotchinga chachikulu kwambiri kuti chidutse.Pakadali pano,OCAili mu magawo atatu ofunikira.Chofunikirachi chakwaniritsidwa panthawi yophunzira.Tikukonzekera kukumana ndi a FDA posachedwa momwe tingathere kuti tikambirane momwe tingakhazikitsire dongosolo lovomerezeka pazambiri za CRL mtsogolomo. "

Pampikisano wofuna kutenga mankhwala oyamba a NASH, Intercept yakhala ikutsogola nthawi zonse ndipo pakadali pano ndi kampani yokhayo yomwe yapeza zidziwitso zoyeserera mochedwa.Monga agonist wamphamvu komanso wachindunji wa farnesoid X receptor (FXR),OCAadapezapo zotsatira zabwino muyeso lachipatala la gawo 3 lotchedwa REGENERATE.Deta idawonetsa kuti apakati mpaka ovuta kwambiri a NASH omwe adalandira Mlingo wambiri waOCAMwa odwalawo, gawo limodzi mwa magawo anayi a zizindikiro za chiwindi cha odwala matendawa zasintha kwambiri, ndipo mkhalidwewo sunawonongeke.

A FDA adalimbikitsa kuti Intercept ipereke zina zowonjezera pakanthawi kochepa komanso chitetezo kuchokera ku kafukufuku wopitilira REGENERATE kuti athandizire.Zotheka za OCAanafulumizitsa chivomerezo, ndipo adanena kuti zotsatira za nthawi yayitali za phunziroli ziyenera kupitilira.

NgakhaleOCAadavomerezedwa kale ku matenda ena osowa chiwindi (PBC), gawo la NASH ndi lalikulu.Akuti NASH imakhudza anthu mamiliyoni ambiri ku United States kokha.M'mbuyomu, banki yosungitsa ndalama ya JMP Securities idati kugulitsa kwakukulu kwa mankhwala a Intercept kumatha kufika mabiliyoni a madola.Kukhudzidwa ndi nkhani zoyipazi, mitengo ya Intercept idatsika pafupifupi 40% Lolemba mpaka $47.25 pagawo lililonse.Mitengo yamakampani ena opanga mankhwala omwe adapanganso NASH yatsikanso.Mwa iwo, Madrigal adatsika pafupifupi 6%, ndipo Viking, Akero ndi GenFit adatsika ndi 1%.

Katswiri wa Stifel Derek Archila adalemba mu lipoti kwa kasitomala kuti kukana kudachitika chifukwa cha zovuta zokhudzana ndi mankhwala zomwe zidachitika muKuyesa kwachipatala kwa OCA, ndiko kuti, odwala ena analandiraChithandizo cha OCA, cholesterol choipa m'thupi chinawonjezeka, zomwe zimawapangitsa kukhala ndi chiopsezo chachikulu cha mtima.Popeza kuti odwala ambiri a NASH ali onenepa kale kapena akudwala matenda a shuga a mtundu wa 2, zotsatira zoyipa zotere zimatha kudzutsa tcheru kwa mabungwe olamulira.Malinga ndi zofunikira za FDA pazowonjezera zoyeserera, Intercept iyenera kudikirira mpaka theka lachiwiri la 2022 kuti amasulire izi.Kuwunika kwakunja kukukhulupirira kuti kuchedwa kwanthawi yayitali kungathe kuwononga gawo lachitsogozo cha Intercept chomwe chidasokonekera, kulola opikisana nawo ena kuphatikiza Madrigal Pharmaceuticals ndi Viking Therapeutics kukhala ndi mwayi wopeza.