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.

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RTTNews | Oct 20, 2020 08:17AM EDT

08:17 Tuesday, October 20, 2020 (RTTNews.com) - 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.

Read the original article on RTTNews ( https://www.rttnews.com/3137576/astellas-pharma-fda-grants-fast-track-designation-for-asp0367-ma-0211-quick-facts.aspx)

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