Orphan-drug designation for resveratrol in Melas (Mitochondrial myopathy, encephalopathy, lactic acidosis, and stroke-like episodes) syndrome provides company with seven years of marketing exclusivity upon receipt of FDA approval. The US orphan drug act was created to provide incentives for companies to develop and market treatments for diseases affecting fewer than 200,000 people in the US.
Christoph Westphal, CEO and vice chair of Sirtris, said: “We are extremely pleased to have received orphan-drug designation in Melas. Clinical testing with resveratrol (SRT501) in this mitochondrial disorder offers the potential to provide an exciting, novel treatment option for the future.”