CORRECTED - UPDATE 1-US FDA staffer supports new use for Bristol drug

Mon Apr 16, 2007 10:55am EDT
 
[-] Text [+]

(Corrects spelling of Avalide in paragraphs 1, 3 and 4.)

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

The drug, first approved in 1997, is already approved 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 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, were not needed, the reviewer also said in the documents posted on the FDA Web site here

Shares of Bristol were up 10 cents, or less than one percent, at $28.42 in early morning trade on the New York Stock Exchange.

 

Featured Broker sponsored link