The most common cause of death in the U.S is heart disease. One in every seven deaths is because of a heart condition, as reported by the American Heart Association. Medicine Co had been trying to get the U.S Food and Drug Administration to approve their product called Cangrelor, since nearly a decade. Cangreloris a blood clot preventer, and on Monday it finally found success when FDA approved the drug.
Medicine Co is a company aiming to lead in intensive care medicine worldwide. Its vision is to be a leading provider of solutions in three areas: acute cardiovascular care, surgery and preoperative care, and serious infectious disease care. The company operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers today in Parsippany, NJ, USA and Zurich, Switzerland.
Cangrelor (also called Kengreal) is an intravenous antiplatelet drug that prevents blood clots in coronary arteries which pump blood to the heart. It is aimed at patients who need PCI or angioplasty, a non-surgical procedure to widen narrowed arteries.
Cangrelor costed Medicine Co $200 million with two unsuccessful trials and a study which drew criticism as well as a rejection from FDA.
FDA told Medicine Co to go back to reanalyzing the data from the previous trail, the Champion-Phoenix trial, in which 11,000 patients participated.
Majority of the independent advisory panel to the FDA got convinced two months ago when Medicine Co tweaked its study and narrowed the indication of the drug and its target population. They felt that the drug should be allowed to be used as a second-line therapy and had a better and safer profile than the clopidogrel, Bristol-Myers Squibb Co’s Plavix.
When the two drugs were compared Cangrelor reduced the occurrence of a heart attack or the need for further procedures to open up the arteries, stated the FDA on Monday. Approximately one in every 170 Kengreal patients had a serious bleed versus approximately one in every 275 clopidogrel patients.
Medicine Co is hopeful to launch the product into the market this July, but the previous failures may cause setback of the drug in the potential market.
The drug is expected to earn about $80-$100 million in the U.S, expects RBC Capital Market’s Adnan Butt. That does nothing in front of the $200 million spent on developing the drug by Medicine Co.