FDA Grants Medivir’s MIV-711 Rare Pediatric and Orphan Drug Status for Legg-Calvé-Perthes


Medivir AB, a leading pharmaceutical company dedicated to developing groundbreaking treatments for cancer in areas of high unmet medical need, has announced that its innovative selective cathepsin K inhibitor, MIV-711, has been granted both Rare Pediatric Disease Designation and Orphan Drug Designation by the FDA for the treatment of Legg-Calvé-Perthes Disease.

This significant milestone underscores Medivir’s commitment to addressing rare pediatric diseases and highlights the potential of MIV-711 as a promising treatment option for patients suffering from Legg-Calvé-Perthes Disease, a rare childhood disorder affecting the hip joint.

With these designations, Medivir is now eligible for various incentives, including tax credits for clinical trial costs, exemptions from certain FDA application fees, and, upon approval, potential market exclusivity for MIV-711 in the treatment of Legg-Calvé-Perthes Disease.