Emergent BioSolutions gains US FDA approval for Ixinity

US biopharma company Emergent BioSolutions (NYSE: EBS) has received US Food and Drug Administration approval for Ixinity (coagulation Factor IX [recombinant]).

Ixinity is an intravenous recombinant human coagulation factor IX therapeutic for the control and prevention of bleeding episodes and for perioperative management in adults and children, ≥12 years of age, with hemophilia B, is a bleeding disorder caused by a mutation on the factor IX gene resulting in a deficiency of clotting factor IX in the blood, which controls bleeding.

Last year, the FDA issued a complete response letter for the New Drug Application of Ixinity, requesting additional analyses of data from completed studies and noted deficiencies in the CMC section of the license application, all of which had to be resolved before approval could be granted by FDA. Emergent gained rights to the product through its $222 million acquisition of Canada’s Cangene Corp (The Pharma Letter December 12, 2013).