Eagle Pharmaceuticals disclosed today that the FDA has issued a Complete Response letter to the company’s New Drug Application (NDA) for Kangio™ (bivalirudin injection), a ready-to-use version of the blood thinner Angiomax®.
Eagle said the FDA opted to hold off approving its Kangio application pending “further characterization of bivalirudin-related substances in the drug product,” a 50-mL vial of liquid bivalirudin
“We are evaluating the FDA’s response and will work closely with the agency to better understand and address their comments regarding Kangio,” Eagle’s President and CEO Scott Tarriff said in a statement. “We remain committed to Kangio as an important new formulation of bivalirudin for intravenous use, offering multiple benefits for patients and care givers.”
Shares of Eagle fell nearly 20% as of 10:10 am from yesterday’s closing price of $53.68, in apparent response to the Complete Response disclosure. Last year, Eagle enjoyed the second best stock performance among publicly traded companies, placing it second on GEN’s List of Top 10 Wall Street Winners of 2015.
Kangio is indicated as an anticoagulant for patients undergoing percutaneous coronary intervention (PCI) with use of a glycoprotein IIb/IIIa inhibitor—PCI patients with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome and/or patients with unstable angina undergoing percutaneous transluminal coronary angioplasty.
Although Kangio has the same active ingredient as Angiomax, sold by The Medicines Co., Eagle says its product eliminates the need for dilution before administration.
Last year, worldwide Angiomax net product sales plummeted to $212 million from $635.7 million in 2014, due to the loss of exclusivity.