Xanthus drug granted orphan status

Xanthus Pharmaceuticals Inc. of Cambridge said today that the Food and Drug Administration has granted orphan drug designation to Xanafide, its treatment of acute myeloid leukemia, or AML., which is still in clinical testing.

If Xanafide ultimately wins FDA approval, the orphan drug designation would entitle Xanthus to exclusive marketing rights of Xanafide for seven years; orphan drug designation is an FDA incentive to encourage drug companies to seek treatments for diseases affecting fewer than 200,000 people in the United States.

"No therapies are currently approved by the FDA for patients with secondary AML, a condition with a grim prognosis," Richard Dean, chief executive of Xanthus, said in a statement. "This designation is part of Xanthus' plan to continue to progress its Xanafide program with the goal of giving patients with secondary AML a new treatment option."
(By Chris Reidy, Globe staff)