India, Oct. 22 -- Nxera Pharma (SOLTF) announced that it has submitted a Marketing Authorization Application (MAA) to South Korea's Ministry of Food and Drug Safety for vamorolone to treat Duchenne muscular dystrophy (DMD), a rare genetic disorder that causes progressive muscle degeneration and weakness.
The application follows the drug's receipt of Orphan Drug Designation and Global Innovative Products on Fast Track (GIFT) designation in South Korea. The GIFT pathway is intended to accelerate the review of innovative medicines for serious diseases, including rare disorders.
Vamorolone is a dissociative corticosteroid designed to maintain anti-inflammatory effects while reducing certain systemic side effects associated with long-term conv...