UPDATE 2-US FDA staffer supports new use for Bristol drug

Mon Apr 16, 2007 12:25pm EDT

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By Susan Heavey

WASHINGTON, April 16 (Reuters) - Earlier use of Bristol-Myers Squibb Co.'s (BMY.N) Avalide to treat some hypertension patients should win U.S. approval, a Food and Drug Administration reviewer said in documents released on Monday.

The drug, co-marketed by Sanofi-Aventis (SASY.PA) (SNY.N), was first approved in 1997 and is already cleared to treat hypertension after use of either irbesartan or hydrochlorothiazide fails to help reach desired blood pressure levels.

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

The drugmaker submitted two new studies to the agency, one investigating Avalide as the first treatment for severe hypertension and another looking at use of the drug in moderate hypertension.

On Wednesday, an FDA panel of outside advisers is scheduled to discuss the data and whether to recommend that the agency approve the new use. The agency is not bound by their decision but usually follows their advice.

The FDA reviewer said data showed the combination drug "was significantly more effective." No new safety problems were found in either study, the staffer added, although more side effects were seen with the highest doses.

Post-approval actions, which could include more studies or patient registries, are not needed, the reviewer also said in the documents posted on the FDA Web site here

Avalide is a type of angiotensin II receptor blocker that aims to treat hypertension, or high blood pressure -- a condition that can increase the risk of heart attack, stroke and other complications.

Side effects include dizziness, headaches and abnormally low blood pressure, among other problems, according to the FDA memo.

Bristol and Sanofi also market irbesartan alone under the brand Avapro.

Deciding how to treat individual patients can be difficult, Bristol said in separate documents also released on Monday. But using Avalide early could help prevent emergency situations and heart complications, the company wrote.

In addition to the two studies, the company also said "data collected during 10 years of post-marketing surveillance provide a reassuring long-term safety profile."

Shares of Bristol were up 19 cents, or less than one percent, at $28.51 in midday trade on the New York Stock Exchange.

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