89bio Gets FDA Breakthrough Designation for Pegozafermin in NASH
2023年9月21日 - 10:07PM
Dow Jones News
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)
Copyright (c) 2023 Dow Jones & Company, Inc.
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