FDA rejects Eagle Pharmaceuticals’ Kangio blood thinner

The drug is a ready-to-use version of The Medicines Co’s blood clot preventer Angiomax, which should also to be taken with aspirin.

It is intended for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI) with use of glycoprotein IIb/IIIa inhibitor, undergoing PCI with, or at risk of, heparin-induced thrombocytopenia (HIT) and thrombosis syndrome (HITTS), and/or with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA).

Kangio features the similar active ingredient as Angiomax, but removes the need for dilution.

The FDA did not approve the marketing application for Kangio in its existing form and requested additional information.

In its complete response letter to the company, the regulator requested additional characterization of bivalirudin-associated substances in the drug product.

Eagle Pharmaceuticals president and CEO Scott Tarriff said: "We are evaluating the FDA’s response and will work closely with the agency to better understand and address their comments regarding Kangio.

"We remain committed to Kangio as an important new formulation of bivalirudin for intravenous use, offering multiple benefits for patients and care givers."

Eagle Pharmaceuticals is focused on developing and commercializing injectable products that address the shortcomings of existing commercially successful injectable products.