Nxera Pharma Submits Marketing Authorization Application for Vamorolone in South Korea

Nxera Pharma has submitted a Marketing Authorization Application (MAA) to the South Korean Ministry of Food and Drug Safety for vamorolone, intended for treating Duchenne muscular dystrophy (DMD). The drug has received Orphan Drug Designation and Global Innovative Products on Fast Track (GIFT) designation in South Korea and is already approved in the US, UK, EU, and China. Nxera aims for regulatory approval by 2027 and plans to launch commercially in 2028.