Sirtris wins orphan drug status for drug candidate
Sirtris Pharmaceuticals Inc. of Cambridge said today that the Food and Drug Administration has granted orphan drug status for resveratrol in the treatment of MELAS syndrome.
MELAS is a progressive and fatal disorder with no known treatments, and seizures, dementia, impaired muscular function, and neurodegeneration can be observed as the disease progresses, Sirtris said.
The Orphan Drug Act rewards companies that develop drugs for rare diseases by giving them seven years to sell each new treatment without competition from other manufacturers; orphan drug status is often granted early in the drug development process, and long before a drug is granted FDA approval for marketing, to give companies a financial incentive to move ahead with their work.
Sirtris is also looking at resveratrol, a SIRT1 activator found in red wine, for other potential uses such as treatments for diseases related to aging, including Type 2 diabetes.
In January, Sirtris said it hopes to bring its first drug to market in 2012 or 2013, and that drug could be a drug candidate called SRT501, a concentrated form of resveratrol, for treating Type 2 diabetes.
(By Chris Reidy, Globe staff)
