Eli Lilly & Co and Japan's Daiichi Sankyo Co won European approval for their blood-thinning drug Efient, also known as prasugrel to treat heart patients with acute coronary syndrome who get artery-clearing angioplasty procedures.
Efient which works by reducing the ability of platelets to stick or clump together, which can cause clogged arteries and lead to a heart attack, was unanimously approved by an advisory panel to the U.S. Food and Drug Administration. The European clearance of the drug follows the advice of the European Medicines Agency panel in December.
The drug is approved to treat patients suffering chest pain or heart attacks that undergo artery-clearing treatment with metal stents to hold open the vessels. It will now be a rival to Sanofi-Aventis SA and Bristol-Myers Squibb Co.’s Plavix, the second-biggest selling drug in the world which is approved for a broader group of patients.
“Using current medical interventions and treatments, people continue to experience recurrent heart attacks and more than 700,000 people die from heart attacks in the European Union each year,” said Takashi Shoda, chief executive officer of Tokyo- based Daiichi, in a statement.
The companies said Efient was approved for heart patients with acute coronary syndrome undergoing an artery-opening procedure and in a study the drug prevented more cardiovascular-related deaths and heart attacks than Plavix. The drug Prasugrel was also seen to reduce the number of blood clots that clogged stents used to prop open treated arteries by 50 %.
The chances of serious bleeding particularly in smaller and older patients were however significantly increased which can be fatal. A lower dose is recommended for smaller, frail patients and the drug isn’t recommended for people over age 75 or those who have suffered a previous stroke. (Harkiran contributed to this report)
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