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

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.”

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. Orphan drug designation qualifies the drug developer for a variety of development incentives, including tax credits for qualified clinical testing, exemptions from certain FDA application fees, and seven years of market exclusivity, if approved. For more information on orphan drug designation, please visit the FDA website, available at https://www.fda.gov/industry/developing-products-rare-diseases-conditions/designating-orphan-product-drugs-and-biological-products.

About nemvaleukin alfa
Nemvaleukin is an investigational, novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor chain, designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity IL-2 receptor complex. The selectivity of nemvaleukin is designed to leverage the proven antitumor effects of existing IL-2 therapy while mitigating certain limitations.

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