Ma ka la 29 o Iune,Ua hoʻolaha ʻia ʻo Intercept Pharmaceuticalsua loaʻa iā ia kahi palapala noi lāʻau hou piha mai ka US FDA e pili ana i kāna FXR agonist obeticholic acid (OCA) no ka fibrosis i hana ʻia e ka non-alcoholic steatohepatitis (NASH) pane pane (CRL).Ua ʻōlelo ka FDA i loko o ka CRL e pili ana i ka ʻikepili i loiloi ʻia a hiki i kēia manawa, manaʻoʻiʻo ʻo nā pōmaikaʻi i manaʻo ʻia o ka lāʻau lapaʻau e pili ana i nā hopena hoʻāʻo histopathology ʻē aʻe ʻaʻole maopopo, a ʻo nā pono o ka mālama ʻana ʻaʻole i ʻoi aku ma mua o nā pilikia kūpono, no laila ʻaʻole ia. kākoʻo i ka ʻae wikiwiki ʻana o OCA no ka mālama ʻana i nā maʻi NASH i kumu i ka fibrosis ate.

ʻO Mark Pruzanski, Pelekikena a me Luna Nui o Intercept, 'ōlelo i nā hopena: "I ka wā o ka loiloi loiloi, ʻaʻole i haʻi aku ka FDA i ka ʻike e pili ana i ka hoʻolalelale ʻana i ka ʻae ʻia o OCA, a ke manaʻoʻiʻo nei mākou ua kūpono nā ʻikepili i waiho ʻia i kēia manawa i nā koi o ka FDA a kākoʻo maopopo i ka pilikia o ka loaʻa kālā o OCA.Minamina mākou i kēia CRL.Ua hoʻonui mālie ka FDA i ka paʻakikī o nā helu hope o ka histological, no laila ke hana nei i kahi pale kiʻekiʻe loa e hala.I kēia manawa,OCAaia wale nō i loko o kahi kī ʻekolu pae.Ua hoʻokō ʻia kēia koi i ka wā o ke aʻo ʻana.Hoʻolālā mākou e hui me ka FDA i ka hiki ke kūkākūkā pehea e hoʻoholo ai i ka hoʻolālā ʻae ʻia ma ka ʻike CRL i ka wā e hiki mai ana.

I ka heihei e hopu i ka lāʻau lapaʻau NASH i helu mua ʻia, ua noho mau ʻo Intercept i ke kūlana alakaʻi a ʻo ia wale nō ka hui i loaʻa i ka ʻikepili hoʻokolohua maikaʻi.Ma ke ʻano he agonist farnesoid X receptor (FXR) ikaika a kikoʻī,OCAua loaʻa mua i nā hopena maikaʻi ma kahi hoʻokolohua lapaʻau 3 i kapa ʻia REGENERATE.Ua hōʻike ʻia ka ʻikepili i loaʻa i ka NASH maʻalahi a koʻikoʻi i loaʻa nā kiʻekiʻe kiʻekiʻe oOCAMa waena o ka poʻe maʻi, ua hoʻomaikaʻi maikaʻi ʻia ka hapahā o nā hōʻailona fibrosis ate o nā maʻi, a ʻaʻole i emi ke kūlana.

Manaʻo ka FDA e hāʻawi ʻo Intercept i nā ʻikepili hou aʻe a me ka palekana mai ka hoʻopaʻa ʻana REGENERATE e kākoʻo.OCA hikika ʻae ʻana i ka wikiwiki, a kuhikuhi ʻia e hoʻomau nā hopena lōʻihi o ka haʻawina.

ʻOiaiOCAua ʻae ʻia ma mua no kahi maʻi ʻē aʻe ʻē aʻe (PBC), nui ke kahua o NASH.Ua manaʻo ʻia e pili ana ka NASH i nā miliona o nā kānaka ma ʻAmelika Hui Pū ʻIa.Ma mua, ua manaʻo ka panakō hoʻopukapuka ʻo JMP Securities e hiki i ke kiʻekiʻe o ke kūʻai ʻana o nā lāʻau lapaʻau Intercept ke hiki i nā piliona kālā.Ma muli o kēia nūhou maikaʻi ʻole, ua hāʻule ke kumukūʻai kumukūʻai o Intercept ma kahi o 40% ma ka Pōʻakahi i $47.25 no kēlā me kēia.Ua hāʻule pū nā kumukūʻai kumukūʻai o nā hui lāʻau lapaʻau ʻē aʻe i kūkulu i ka NASH.Ma waena o lākou, ua hāʻule ʻo Madrigal ma kahi o 6%, a ua hāʻule ʻo Viking, Akero a me GenFit ma kahi o 1%.

Ua kākau ʻo Stifel analyst Derek Archila i kahi hōʻike i ka mea kūʻai aku ʻo ka hōʻole ʻana ma muli o nā hopena pili pili i ka mālama ʻana i loaʻa maOCA hoao ana, ʻo ia hoʻi, loaʻa i kekahi mau maʻiLapaʻau OCA, piʻi aʻe ka cholesterol ʻino i loko o ke kino, ʻo ia hoʻi e hoʻonui iā lākou i ka nui o ka pilikia cardiovascular.Ma muli o ka nui o nā poʻe maʻi NASH i ke kaumaha a i ʻole e loaʻa ana i ka maʻi diabetes type 2, hiki i ia mau hopena ke hoʻāla i ka makaʻala o nā keʻena hoʻoponopono.E like me nā koi a ka FDA no ka ʻikepili hoʻāʻo hou, pono paha ʻo Intercept e kali a hiki i ka hapa lua o 2022 e wehewehe i kēia mau ʻikepili.Manaʻo ka nānā ʻana o waho e hiki ke hoʻopau ʻia kahi lohi lōʻihi o ke alakaʻi mua o Intercept, e ʻae ana i nā mea hoʻokūkū ʻē aʻe me Madrigal Pharmaceuticals a me Viking Therapeutics e loaʻa i kahi manawa e hopu ai.