A long-delayed blood thinner from AstraZeneca PLC won U.S. approval Wednesday, posing new competition to the multibillion-dollar blockbuster pill Plavix.
The Food and Drug Administration said it approved Brilinta to reduce heart attacks and prevent deaths in patients with acute coronary syndrome, or clogged arteries. More than 1 million U.S. patients are hospitalized each year with heart attacks, stroke and other complications of the condition, according to the American Heart Association.
The drug works by preventing the formation of blood clots that can block blood flow to the heart. The twice-a-day tablet is designed to be used in combination with low doses of aspirin.
Twice last year, in September and December, the FDA delayed making a decision on the drug, which already is available in Europe and Canada.
An international, 18,000-patient study conducted by AstraZeneca showed that patients taking Brilinta instead of Plavix were less likely to experience various heart-related problems, including heart attack, stroke and death. The drug's label will note that benefit, but will also contain a boxed warning that Brilinta should not be used with high-dose aspirin, which reduces its effectiveness. In company trials, U.S. patients taking the drug fared worse than patients in many foreign countries that traditionally use lower doses of aspirin.
The label will also include a box warning about bleeding side effects, which are common to most blood-thinning drugs. Roughly 11 percent of patients taking both Plavix and Brilinta experienced internal bleeding in company trials
Sanofi SA and Bristol-Myers Squibb Co.'s drug Plavix currently dominates the market for prescription blood thinners. The drug was the second best-selling pharmaceutical in the world last year, with $8.8 billion in sales. Analysts estimate Brilinta could reach sales of $1 billion by 2015.
A rival blood thinner Effient from Eli Lilly & Co. has faced an uphill climb since winning approval in 2009. The drug posted only $115 million in sales last year.