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

March 11, 2021

Via: BioSpace

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. “The accumulating data from the nemvaleukin program have continued to support the clinical profile we anticipated in targeting the IL-2 pathway, and we look forward to continuing our momentum with the ARTISTRY development program this year.”

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