FDA rejects Eagle Pharma's reformulated Angiomax

Eagle CEO Scott Tarriff

The FDA rejected Eagle Pharmaceuticals' ($EGRX) ready-to-use version of the blood thinner Angiomax, requesting more information on the injectable treatment and putting off the company's hopes of a commercial launch.

Eagle's treatment, Kangio, is a 50-mL vial of liquid bivalirudin, long sold as Angiomax, that the company claims could be a convenient on-demand anticoagulant for patients in critical care. Eagle submitted the drug with hopes of winning approval for use in stenting and angioplasty.

In its rejection, the FDA asked for "further characterization of bivalirudin-related substances in the drug product," Eagle said, and the company promised to sit down with regulators and find a path forward as soon as possible.

"We are evaluating the FDA's response and will work closely with the agency to better understand and address their comments regarding Kangio," Eagle 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 caregivers."

Eagle went public in 2014, pulling off a $50 million IPO on the promise of its ready-to-use takes on established drugs. Last year, Teva Pharmaceutical ($TEVA) bought into Eagle's fast-acting version of its own Treanda in a $120 million deal, picking up U.S. rights to the in-development non-Hodgkin lymphoma therapy.

- read the statement

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