FDA Grants Alkermes Orphan Drug Designation for the Treatment of Mucosal Melanoma

WASHINGTON, DC – The U.S. Food and Drug Administration (FDA) has recently granted orphan drug designation for the treatment of mucosal melanoma to Alkermes’ investigational engineered interleukin-2 (IL-2) variant immunotherapy, nemvaleukin alfa (“nemvaleukin,” formerly referred to as ALKS 4230). Under the Orphan Drugs Act (ODA), the FDA may grant orphan drug designation to drugs and biologics that are intended to treat diseases or conditions affecting fewer than 200,000 people in the U.S., which mucosal melanoma falls under. Learn more from their press release here.