Medivir Partner Infex Therapeutics Receives FDA QIDP Designation
Medivir AB has announced 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.
During 2022, Infex has presented additional preclinical data and communicated its intention to initiate regulatory safety studies to enable a Phase I clinical trial application in 2023. The QIDP designation is a significant step forward in the development of MET-X. Under the terms of the licensing agreement, Medivir is entitled to a share of potential future revenues from the MET-X programme.
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