Medivir AB announced that their investigational drug candidate, MIV-711, has been granted Fast Track designation by the Food and Drug Administration (FDA).

MIV-711 is intended to treat osteoarthritis (OA), aiming to slow or reverse degeneration caused by OA making it a disease-modifying osteoarthritis drug (DMOAD). There are currently no DMOADs approved for use in OA. MIV-711 is a selective inhibitor of cathepsin K, the main protease involved in breaking down collagen in bones and cartilage. 

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Findings from a Phase 2a study demonstrated the potential of MIV-711 to benefit patient’s joint structure. The FDA previously cleared an MIV-711 Investigational New Drug application (IND).

“This [Fast Track designation] underscores the high unmet medical need for a product that may address the disease progression in OA,” said Åsa Holmgren, Medivir´s EVP Strategic Regulatory Affairs and Market Access. The current standard of care for OA patients is based on lifestyle changes and use of analgesics.

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