FDA grants Medivir's MIV-711 Rare Pediatric Disease Designation and Orphan Drug Designation for the treatment of Legg-Calve-Perthes Disease.

Medivir AB, a pharmaceutical company, has received Rare Pediatric Disease Designation and Orphan Drug Designation from the FDA for its drug MIV-711, a selective cathepsin K inhibitor, for the treatment of Legg-Calve-Perthes Disease (LCPD). LCPD is a serious disease that primarily affects individuals aged from birth to 18 years and currently has no effective treatments. MIV-711 has shown promising results in preventing bone degradation and deformity in animal models and clinical studies, making it a potential treatment option for LCPD. The designation allows for fast track review and the possibility of receiving a Priority Review Voucher from the FDA. [Extracted from the article]