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)
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