By Denny Jacob
Mirum Pharmaceuticals's volixibat was granted breakthrough therapy designation by the Food and Drug Administration as a potential treatment for cholestatic pruritus for those with primary biliary cholangitis.
The biopharmaceutical company said the regulatory designation was based on a positive interim analysis of a Phase 2b study. The confirmatory portion of the study is ongoing with completed enrollment expected in 2026.
Cholestatic pruritus is an itchy skin condition related to liver diseases. Primary biliary cholangitis is a chronic autoimmune disease which damages the liver's bile ducts.
The FDA's breakthrough therapy designation aims to expedite the development and review of drugs that are intended to treat serious or life-threatening diseases.
Write to Denny Jacob at denny.jacob@wsj.com
(END) Dow Jones Newswires
October 10, 2024 09:13 ET (13:13 GMT)
Copyright (c) 2024 Dow Jones & Company, Inc.
免责声明：投资有风险，本文并非投资建议，以上内容不应被视为任何金融产品的购买或出售要约、建议或邀请，作者或其他用户的任何相关讨论、评论或帖子也不应被视为此类内容。本文仅供一般参考，不考虑您的个人投资目标、财务状况或需求。TTM对信息的准确性和完整性不承担任何责任或保证，投资者应自行研究并在投资前寻求专业建议。