Eagle Pharma files RTU bivalirudin at FDA for percutaneous coronary interventions.

Eagle Pharmaceuticals, Inc. has submitted a 505(b)(2) New Drug Application (NDA) to the FDA for its novel ready-to-use bivalirudin product (“RTU bivalirudin”). This product is a stable liquid intravenous formulation of bivalirudin, the same active ingredient as in The Medicine Company’s Angiomax (bivalirudin). U.S. sales of Angiomax were approximately $600M for the twelve months ended December 31, 2014.

This 505(b)(2) NDA requests FDA approval of Eagle’s RTU bivalirudin product for the treatment of patients: (1) undergoing percutaneous coronary intervention (PCI) with use of glycoprotein IIb/IIIa inhibitor, (2) undergoing PCI with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome, and/or (3) with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA). RTU bivalirudin is intended for use with aspirin.

Comment:Eagles is pursuing approval under the 505(b)(2) pathway at the FDA, which permits US regulators to rely on other applications' data to conduct the agency's review. The liquid RTU bivalirudin formulation would allow for immediate administration, with no reconstitution nor initial dilution required – reducing work flow and the risk of dosing errors.