Epizyme's EPZ-5676 For Treatment Of Acute Leukemia Granted Orphan Drug Status

(RTTNews) - Epizyme, Inc., (EPZM) Friday said its EPZ-5676 for the treatment of acute leukemias has been granted orphan drug designation by the U.S. Food and Drug Administration or the FDA. EPZ-5676 is a small molecule inhibitor of DOT1L created with Epizyme's proprietary product platform, for the treatment of acute leukemias in which the MLL gene is rearranged due to a chromosomal translocation.

The company said orphan drug designation allows special incentives for sponsors planning to test a product for use in a rare disease or condition. These incentives include tax credits, research and development grant funding and reduced filing fees during development or at the time of application for marketing approval. Once approved, the product may qualify for seven years of marketing exclusivity independent of any other intellectual property.