Home » Agency Grants RMAT Designation to Capricor’s Duchenne Cell Therapy
Agency Grants RMAT Designation to Capricor’s Duchenne Cell Therapy
Drugs Regulatory Affairs
Capricor’s lead investigational cell therapy for Duchenne muscular dystrophy, CAP-1002, received the FDA’s regenerative medicine advanced therapy designation.
The agency expedites reviews for products with the RMAT designation, which is granted to regenerative medicine therapies that clinically prove their potential to address unmet medical needs in the treatment of serious conditions.
The investigational cell therapy has also received an orphan drug designation in addition to a rare pediatric disease designation.