Astria Therapeutics, Inc. announced that the STAR-0215 development program has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of Hereditary Angioedema (HAE), a rare genetic disorder that causes severe unpredictable attacks of swelling throughout the body. STAR-0215 is currently being evaluated in the ALPHA-STAR clinical trial in people with HAE, with initial proof-of-concept results expected in mid-2024. The FDA Fast Track process is designed to expedite the development and review of therapies to treat serious or life-threatening conditions and that demonstrate the potential to address unmet needs.

Companies that receive Fast Track designation for a product candidate are able to submit New Drug Applications (NDA) for such candidate on a rolling basis, potentially expediting the FDA review process, and benefit from more frequent communication with the FDA to discuss all aspects of clinical development. In addition, drugs that receive Fast Track designation may be eligible for a priority review if certain criteria are met.