Blood clot preventer Kengreal Gets FDA Approval
The US Food and Drug Administration has given green signal to The Medicines Company’s bloodthinner Kengreal in patients undergoing percutaneous coronary intervention (PCI), heart procedure.
The approval has come after many setbacks and over a year after its rejection and request for more analysis and information. The PCI is a procedure to open a blocked or narrowed coronary artery with an aim to improve blood flow to the heart muscle.
In America, PCI is performed on or around 500,000 people on annual basis. The FDA said Kengreal (cangrelor) prevents platelets from accumulation and reduces the risk of serious clotting complications with regard to the procedure.
The FDA has given permission on the basis of a clinical trial in which Kengreal (cangrelor) was compared with Plavix (clopidogrel) in over 10,000 participants. The clinical trial unveiled that the blood thinner significantly reduced the incidents of heart attack.
Incidents of serious bleeding were quite low. “I believe that intravenous cangrelor has the potential to substantially improve outcomes for patients with cardiovascular disease because of its immediate onset of near complete platelet inhibition with rapid reversibility”, said Gregg Stone, Director of Cardiovascular Research and Education, Columbia University Medical Center.
As per data, Medicines Co has funneled around $200 million into the development of blood thinner over the past 10 years. The company said Cangrelor can enter in the market as early as June. But as per experts, series of setbacks have affected the potential market of the drug.