The U.S. Food and Drug Administration granted fast-track status to Astellas Pharma Inc.'s experimental medicine ASP0367/MA-0211 for a certain rare disease.
Astellas Pharma is developing ASP0367/MA-0211 as a potential treatment of primary mitochondrial myopathies, or PMM, a group of rare disorders characterized by mutations in the mitochondria that result in muscle fatigue, muscle pain and muscle wasting.
The Tokyo-based pharmaceutical company gained a portfolio of mitochondrial drugs from its acquisition of Mitobridge Inc. in 2018.
There are no FDA-approved treatments for PMM, Astellas noted in a news release.
Astellas will conduct a phase 2/3 study called Mountainside to assess the drug's efficacy and safety in PMM patients.