US FDA calls for additional data on Eagle's Kangio

Shares of USA-based Eagle Pharmaceuticals (Nasdaq: EGRX) slumped 18.96% to $43.50 on heavy trading volume on Friday afternoon, after the Food and Drug Administration rejected its drug Kangio (bivalirudin injection), a ready-to-use version of the blood thinner Angiomax.

Eagle revealed that it had received a Complete Response Letter from the FDA for its Kangio New Drug Application for a ready-to-use (RTU), stable liquid intravenous formulation of 5mg/mL bivalirudin in a 50-mL vial intended for use as an anticoagulant in 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 (HIT) and thrombosis syndrome (HITTS), and/or (3) with unstable angina undergoing percutaneous transluminal coronary angioplasty (“PTCA”).

The FDA issues CRLs to communicate that its initial review of an application is complete; however, it cannot approve the application in its present form and request additional information. In its letter to Eagle, the FDA requested further characterization 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.