Bristol-Myers' Avalide Reviewed for Expanded Use (Update1)

By Lisa Rapaport

April 16 (Bloomberg) -- Bristol-Myers Squibb Co.'s blood pressure drug Avalide should be approved as an initial treatment only for patients with severe hypertension, a U.S. drug reviewer said.

The pill isn't appropriate for routine use in hypertension cases before other medicines are tried, a medical officer of the Food and Drug Administration said today in recommendations posted on the agency's Web site. An FDA advisory committee will consider April 18 whether to recommend expanded use of the drug.

Avalide, a combination of the blood pressure medicines irbesartan and hydrochlorothiazide, is currently approved for use in patients after treatment with a single medicine fails. Sales of the drug rose 12 percent to $1.1 billion last year.

Bristol-Myers, based in New York, has asked the FDA to clear Avalide for use as a first-line therapy in patients with hypertension.

The drug should be used initially only when ``the hypertension is severe enough that the value of achieving prompt blood pressure control exceeds the risk of initiating combination therapy,'' according to the FDA staff report.

Ken Dominski, a spokesman for Bristol-Myers, said he hadn't seen the FDA documents and couldn't comment.

Shares of Bristol-Myers rose 14 cents to $28.46 at 4:03 p.m. in New York Stock Exchange composite trading.

To contact the reporter on this story: Lisa Rapaport in New York at Lrapaport1@bloomberg.net

Last Updated: April 16, 2007 16:09 EDT

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