Alkermes: Nemvaleukin Alfa Gets UK MHRA's Innovation Passport Designation To Treat Mucosal Melanoma

Irish biopharmaceutical company Alkermes plc (ALKS) announced Tuesday that UK regulatory body, the Medicines and Healthcare products Regulatory Agency or MHRA, has granted an Innovation Passport designation to its immunotherapy nemvaleukin alfa (nemvaleukin) to treat mucosal melanoma.

nemvaleukin alfa is the company's investigational, novel engineered interleukin-2 (IL-2) variant immunotherapy.

The Innovation Passport designation, which has been granted under the Innovative Licensing and Access Pathway or ILAP. The designation is the entry point to the ILAP, which was launched by the MHRA in January 2021 to accelerate the development of and facilitate patient access to medicines.

The benefits of ILAP include access to a range of development tools, such as the potential for a 150-day accelerated Marketing Authorization Application or MAA assessment, rolling review and a continuous benefit-risk assessment.

The U.S. Food and Drug Administration previously granted Orphan Drug designation and Fast Track designation to nemvaleukin to treat mucosal melanoma.

Alkermes' Nemvaleukin is currently the most advanced IL-2-based immuno-therapy in clinical development, with two actively recruiting, potentially registrational studies, ARTISTRY-6 and ARTISTRY-7 in mucosal melanoma and platinum-resistant ovarian cancer, respectively.

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