A committee of medical experts says the Food and Drug Administration should support the expanded use of the
blood-pressure drug Avalide.
By a 7-0 vote, the panel said Wednesday that Avalide, which the New York drugmaker licenses from
, should be permitted as a first-line therapy.
Avalide, which combines two medications, is now approved only if an initial hypertension treatment doesn't work. The FDA usually follows its advisory panels' suggestions.
Along with a companion drug Avapro, Avalide contributed $1.1 billion in worldwide sales last year, including $647 million in the U.S. Bristol-Myers Squibb doesn't provide separate figures for the drugs, whose combined sales accounted for 6% of corporate revenue and ranked fourth among the company's products.
The FDA approved both in September 1997.
Avapro and Avalide belong to the class of blood-pressure drugs known as angiotensin II receptor blockers. They both contain the ingredient irbesartan. Avalide also contains a diuretic, hydrochlorothiazide, which helps guard against fluid retention.
The company's stock closed down 3 cents at $28.26.