Eagle Pharma Plunges as the FDA Rejects Blood Thinner Kangio

Eagle Pharma Plunges as the FDA Rejects Blood Thinner Kangio
March 18, 2016
By Alex Keown, BioSpace.com Breaking News Staff

WOODCLIFF LAKE, N.J. – Eagle Pharmaceuticals ’ stock is down nearly 20 percent after the U.S. Food and Drug Administration (FDA) rejected its blood clotting medication for certain patients undergoing heart surgery.

This morning specialty pharmaceutical company Eagle announced it received a Complete Response Letter about Kangio (bivalirudin), an intravenous clotting drug designed to help patients undergoing percutaneous coronary intervention (PCI) with use of glycoprotein IIb/IIIa inhibitor or patients undergoing PCI at risk of heparin-induced thrombocytopenia and thrombosis syndrome. A complete response letter is issued by the FDA noting the regulatory body has completed its review of a drug, but cannot approve the drug in its present form. In its letter to Eagle, the FDA requested further characterization of bivalirudin-related substances in the drug product. Eagle said it plans to work with the FDA to determine a path forward for the drug.

“We are evaluating the FDA’s response and will work closely with the agency to better understand and address their comments regarding Kangio,” Scott Tarriff, president and chief executive officer of Eagle Pharmaceuticals, 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.”

Eagle stock hit a low of $41.79 this morning, falling from its Thursday closing price of $53.68 per share. Like many other biotech stocks, Eagle Pharmaceuticals has been on a steady decline since the start of the year. Since mid-December the stock has fallen from a year-high of $99.07 per share.

While the stock is down, recent news for Eagle has not been all that bad. In February the company announced the FDA granted Fast Track Designation to its Ryanodex (dantrolene sodium for injectable suspension) for the treatment of exertional heat stroke, an investigational new indication for the product. The FDA's Fast Track program facilitates the development and review of drugs intended to treat serious conditions and address an unmet medical need. Ryanodex is currently indicated for the treatment of malignant hyperthermia.

In December, Eagle won FDA approval for its non-alcohol formula of Docetaxel Injection, for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer. Docetaxel Injection is the first alcohol-free formulation approved in the U.S., the company said.

“As the first alcohol-free formulation approved in the U.S., we believe the benefits of this novel formulation will provide an option for patients with alcohol sensitivity or a preference for an alcohol-free treatment,” Tarriff said in a statement at the time of approval.

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