89bio Gets FDA Breakthrough Designation for Pegozafermin in NASH
By Colin Kellaher
89bio has won U.S. Food and Drug Administration breakthrough-therapy designation for its pegozafermin drug candidate in nonalcoholic steatohepatitis, a chronic liver condition commonly known as NASH.
The San Francisco clinical-stage biopharmaceutical company on Thursday said the designation is supported by positive data in NASH patients from a Phase 2b study of pegozafermin.
The FDA's breakthrough-therapy designation aims to expedite the development and review of a drug for serious conditions when preliminary clinical evidence shows the drug may show substantial improvement over available therapies.
89bio said it plans to hold discussions with regulatory agencies regarding its NASH Phase 3 program in the fourth quarter.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
September 21, 2023 08:52 ET (12:52 GMT)
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