Alkermes Announces FDA Orphan Drug Designation for Nemvaleukin Alfa for Treatment of Mucosal Melanoma

Source: Biospace, March 2021

DUBLIN, March 11, 2021 /PRNewswire/ — Alkermes plc (Nasdaq: ALKS) today announced that nemvaleukin alfa (“nemvaleukin”, formerly referred to as ALKS 4230), the company’s investigational engineered interleukin-2 (IL-2) variant immunotherapy, has been granted orphan drug designation for the treatment of mucosal melanoma by the U.S. Food and Drug Administration (FDA).

“This orphan drug designation is an important milestone for the nemvaleukin alfa program and underscores nemvaleukin’s potential clinical utility in mucosal melanoma, a particularly aggressive form of melanoma for which treatment options remain limited,” said Jessicca Rege, Ph.D., Vice President, Head of Oncology at Alkermes.