Alnylam Pharma's ALN-AT3 Granted Orphan Drug Status By FDA - Quick Facts

(RTTNews) - Alnylam Pharmaceuticals Inc. (ALNY), Wednesday said that the U.S. Food and Drug Administration has granted Orphan Drug Designation for its investigational drug - ALN-AT3, for the treatment of hemophilia B.

Alnylam is developing ALN-AT3, a subcutaneously administered RNAi therapeutic targeting antithrombin, for the treatment of hemophilia, including hemophilia A, hemophilia B, and hemophilia A or B with inhibitors and other rare bleeding disorders.

The company plans to file an investigational new drug application for ALN-AT3 in the fourth quarter of 2013 and initiate a phase I clinical trial in early 2014.