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Astellas Pharma: FDA Grants Fast Track Designation For ASP0367/MA-0211 - Quick Facts

(RTTNews) - Astellas Pharma Inc. (ALPMY, ALPMY) announced that the FDA has granted Fast Track designation for the development of ASP0367/MA-0211 as a potential treatment for primary mitochondrial myopathies. There is no FDA-approved treatment for primary mitochondrial myopathies, a rare disease with a high unmet medical need.

Astellas Pharma said ASP0367 will be entering a phase II / III study (MOUNTAINSIDE) to validate the efficacy and safety in PMM patients. The Fast Track designation is anticipated to accelerate the clinical development of ASP0367.

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