Astria Therapeutics Gets FDA Fast-Track Designation for Hereditary Angioedema Treatment
By Ben Glickman
Astria Therapeutics said Thursday it has received fast-track designation from the U.S. Food and Drug Administration for its treatment of hereditary angioedema.
The Boston-based biopharmaceutical company said STAR-0215, a monoclonal antibody inhibitor, is currently being tested in a Phase 1b/2 trial, with results expected in mid-2024.
FDA fast-track status is given to treatments for serious or life-threatening conditions with an unmet need. The company said HAE is a rare genetic disorder which can cause unpredictable bouts of swelling in the body.
Fast-track designation gives Astria the option to submit a New Drug Application to the FDA on a rolling basis and have more regular discussions with the FDA prior to approval.
Write to Ben Glickman at ben.glickman@wsj.com
(END) Dow Jones Newswires
July 20, 2023 08:29 ET (12:29 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.-
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