FDA issues complete response letter for Kangio (bivalirudin injection) for PCI- Eagle Pharma

Eagle Pharmaceuticals announced that it has received a Complete Response Letter from the FDA for its Kangio (bivalirudin injection), 505(b)(2) New Drug Application for a ready-to-use (“RTU”), stable liquid intravenous formulation of 5 mg/mL bivalirudin in a 50 mL vial intended for use as an anticoagulant in patients: (1) undergoing percutaneous coronary intervention with use of glycoprotein IIb/IIIa inhibitor, (2) undergoing PCI with, or at risk of, heparin-induced thrombocytopenia (“HIT”) and thrombosis syndrome and/or (3) with unstable angina undergoing percutaneous transluminal coronary angioplasty.

The FDA issues Complete Response Letters to communicate that their initial review of an application is complete, but they cannot approve the application in its present form and request additional information. In its letter to Eagle, the FDA requested further characterisation of bivalirudin-related substances in the drug product. Eagle will work directly with the FDA to determine an appropriate path forward to address the comments.

Comment: Eagle’s RTU bivalirudin product, which contains the same active ingredient as Angiomax, is administered as an IV solution at the same dose and rate. If approved, Eagle’s liquid formulation will allow for immediate administration, with no reconstitution nor initial dilution required, potentially reducing work flow and the risk of dosing errors.