Medivir partner Infex Therapeutics receives FDA QIDP designation
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Wednesday, January 11, 2023
STOCKHOLM, Jan. 11, 2023 /PRNewswire/ -- Medivir AB (Nasdaq Stockholm: MVIR) announced today that its partner Infex Therapeutics, a leading anti-infectives specialist, has been granted Qualified Infectious Disease Product (QIDP) designation for MET-X by the U.S. Food and Drug Administration (FDA).
Key Points:
- STOCKHOLM, Jan. 11, 2023 /PRNewswire/ -- Medivir AB (Nasdaq Stockholm: MVIR) announced today that its partner Infex Therapeutics, a leading anti-infectives specialist, has been granted Qualified Infectious Disease Product (QIDP) designation for MET-X by the U.S. Food and Drug Administration (FDA).
- MET-X is the Company's broad spectrum Metallo-beta-lactamase inhibitor (MBLI) based on the MBLI program outlicensed by Medivir in 2017 to the AMR Centre, which changed its name to Infex Therapeutics in 2020.
- QIDP designation is a U.S. incentive scheme designed to encourage the development of innovative new drugs to treat serious or life-threatening infections.
- The designation gives MET-X an accelerated FDA regulatory pathway, including priority review, fast-track designation and an additional five years of market exclusivity upon regulatory approval.