Panel backs new use of Bristol hypertension drug

WASHINGTON (Reuters) - A U.S. advisory panel unanimously urged regulators to approve earlier use of a Bristol-Myers Squibb Co. drug to treat hypertension, the company and the Food and Drug Administration said on Wednesday.

Avalide, co-marketed by Sanofi-Aventis, was approved in 1997 and is cleared to treat hypertension after either of the drugs irbesartan or hydrochlorothiazide fails to bring blood pressure to desired levels.

Bristol-Myers is seeking FDA approval to do away with that requirement and market Avalide as a first option for patients with severe hypertension who are unlikely to lower their blood pressure with just one drug.

Avalide combines irbesartan and hydrochlorothiazide.

FDA and Bristol-Myers officials said the panel voted 7-0 to recommend approval of Avalide as an initial option for treating high blood pressure, which can raise the risk of having a heart attack, stroke or other complications. Members also urged further study on elderly patients and people with kidney dysfunction, FDA spokeswoman Sandy Walsh said.

The FDA usually follows panel recommendations. An FDA reviewer had already said the expanded use should be approved.

Bristol-Myers and Sanofi also market irbesartan by itself under the name Avapro.