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.
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.
Medivir receives FDA Fast Track Designation for MIV-711 for the treatment of OA [press release]. Stockholm, Sweden: Medivir; Accessed October 31, 2017.
This article originally appeared on MPR