Panel Recommends Blood Thinner
WASHINGTON (AP) _ A drug designed to thin patients’ blood and lower their risk of heart attack and stroke won an advisory committee’s recommendation for federal approval Friday. Studies showed the drug did those jobs better than aspirin.
The Food and Drug Administration advisers voted 10-1 to recommend that the agency approve marketing of Clopidogrel, which is being developed jointly by the drug companies Sanofi Inc. and Bristol-Myers Squibb.
The FDA is not required to follow the recommendation of the advisory committee but generally does.
A three-year international clinical study, paid for by the drug companies, assessed the value of the drug among more than 19,000 patients who previously had suffered heart attack, stroke or arterial disease. It compared the effects of the test drug against ordinary aspirin.
Both drugs have the effect of preventing blood clots. At the suggestion of doctors, many Americans in recent years have begun taking half an aspirin or a ``baby aspirin″ each day.
The study showed that Clopidogrel reduced the risk of heart attack or stroke by about a third, while aspirin lowered the risk by about one-quarter. Aspirin also caused slightly more digestive bleeding.
While recommending approval of Clopidogrel, the advisory committee also called for its use to be limited to the same patient population included in the clinical study: those who have suffered heart attack, stroke or who have peripheral artery disease.
Analysts have suggested that use of the new drug may well depend on its cost in comparison to aspirin, which costs only pennies.