(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.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.