FDA grants orphan designation for MELAS syndrome drug

WASHINGTON Sirtris Pharmaceuticals has been granted orphan drug designation for resveratrol by the Food and Drug Administration, according to published reports.

Resveratrol is a drug used to treat MELAS syndrome, a progressive fatal aging disease that produces symptoms of muscle weakness, fatigue, recurrent headaches and seizures. The government’s grant is usually offered in cases in which companies are discovering treatments for rare drugs, and the grant would allow the company to speed up their testing period.

Sitris has decided to focus on the SIRT1 gene, which is a gene tied to the aging process. SIRT1 is being studied as a possible source in treating MELAS or type 2 diabetes. According to published reports, the grant has resulted in Sitris being offered seven years of marketing exclusivity for its formulation of resveratrol.