The U.S Food and Drug Administration (FDA) has rejected a drug called Kangio which aimed to prevent blood clot in certain patients undergoing heart surgery. The drug was presented by Eagle Pharmaceutical Inc. (NASDAQ: EGRX) and asked for further details on Friday.
Kangio is a ready-to-use version of The Medicines Co’s blood clot preventer called Angiomax. The previous version included the need for the drug to be reconstituted with water and then further diluted before administered, as reported by Reuters.
The reason for Kangio’s rejection is that the FDA has requested additional information about a substance in the drug product. The drug-maker announced in a press release that they will work directly with the FDA to determine an appropriate path to address the comments.
“We are evaluating the FDA’s response and will work closely with the agency to better understand and address their comments regarding Kangio,” said Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.
Tarriff added that they remain committed to Kangio as an important new formulation of bivalirudin for intravenous use, which according to him offers multiple benefits for patients and caregivers.
Recently, heart disease has become the leading cause of deaths in the U.S. One in every seven American deaths are due to heart-related issues, according to the American Heart Association.
A drug improvement
The original drug, Angiomax, was approved by the FDA in 2000. Its use included the prevention of blood clots in patients undergoing percutaneous coronary intervention (PCI) or angioplasty, which aims to widen narrowed or obstructed arteries in the heart.
Angiomax’s creator, The Medicines Co, has been struggling since it lost patent protection for its emblematic drug. As a direct consequence, the company had to review strategic options, which included a potential sale of the entire business.
After Kangio’s rejection by the FDA, Eagle Pharmaceuticals’ shares were down about 20 percent at $42.97, in light premarket trading this Friday.