Zafgen granted orphan drug designation for beloranib by EC

Zafgen announced that the European Commission, or EC, has granted orphan drug designation for beloranib for the treatment of Prader-Willi syndrome, or PWS, a rare disease. Orphan Drug Designation by the European Commission provides regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union, and where no satisfactory treatment is available. In addition to a 10-year period of marketing exclusivity in the EU after product approval, orphan drug designation provides incentives for companies seeking protocol assistance from the EMA during the product development phase, and direct access to centralized marketing authorization.