FDA grants resveratrol orphan-drug status

[Guest guest]

link:

http://www.bostonherald.com/business/healthcare/view.bg?articleid=1084650

full text:

FDA gives fast-track approval status to Sirtris drug

By McConville | Thursday, April 3, 2008 |

http://www.bostonherald.com | Healthcare

The United States Food and Drug Administration has granted Sirtris

Pharmaceuticals orphan-drug designation for resveratrol in the

treatment of the rare MELAS syndrome.

The government grants orphan-drug designation to companies that are

developing possible treatments for rare diseases, and the designation

allows companies to fast-track their usually lengthy testing period.

And in this case, the designation means that Sirtris will have seven

years of marketing exclusivity for its propriety formulation of

resveratrol.

The Cambridge-based biopharmaceutical company headed by Chief

Executive Christoph Westphal is working to develop small molecule

drugs to treat diseases of aging.

In particular, the company's researchers are targeting SIRT1, a gene

tied to the aging process, as the possible source for new ways to

treat MELAS and Type 2 diabetes.

MELAS is a progressive and fatal disorder with no known treatments.

The earliest symptoms include muscle weakness, fatigue, recurrent

headaches and seizures.

It is caused by a point mutation in mitochondrial DNA, and in

preclinical testing, activation of the SIRT1 enzyme has been shown to

increase the number and function of mitochondria.