UPDATE 2-Bristol, AZ diabetes pill meets criteria -FDA staff

Mon Mar 30, 2009 11:53am EDT

* Expert panel to review Bristol, AZ drug Wednesday

* FDA staff: some missing information clouds some data

* Bristol says saxagliptin shows no heart risk

* FDA decision expected by April 30

* Share of both companies higher (Adds details on drug, background, share prices, byline)

By Susan Heavey

WASHINGTON, March 30 (Reuters) - The U.S. Food and Drug Administration said analyses of Bristol-Myers Squibb Co's (BMY.N) experimental diabetes drug showed it met the agency's new guidelines for heart risk in documents released on Monday.

The pill, called saxagliptin, or Onglyza, is being developed with AstraZeneca Plc (AZN.L) (AZN.N).

Shares of Bristol were up 2.5 percent and AstraZeneca stock was up 3.6 percent in late morning trade, both on the New York Stock Exchange.

FDA staff documents were released ahead of a public meeting scheduled for Wednesday to discuss whether to recommend approval of the medicine.

The meeting is the first of a two-day gathering of FDA's outside experts to discuss new diabetes treatments after the agency released guidelines in December seeking closer company scrutiny of possible heart damage.

On Thursday the panel will discuss Novo Nordisk's (NOVOb.CO) liraglutide injection that the company aims to sell under the brand name Victoza.

The meetings are expected to offer the first insights into how the FDA plans to apply its new criteria to the $6 billion diabetes market. Government estimates show nearly 24 million Americans have diabetes, mostly type 2 diabetes linked with obesity, poor diet and lack of exercise.

Bristol, which submitted its clinical trial results to the FDA for review before the guidelines were issued, was asked to analyze data it already had for potential heart risks.

The FDA said both agency and company analyses showed the drug met the agency's guidelines. But it added that "because of the retrospective nature of these analyses," in some cases there was "insufficient information to definitively determine whether a cardiovascular event of interest occurred."

In separate documents also released on Monday, Bristol said saxagliptin helped control patients' blood sugar levels and was "well tolerated with no evidence of an increase in CV (cardiovascular) risk."

If approved, saxagliptin would compete against Merck & Co Inc's (MRK.N) blockbuster drug Januvia. Both are dipeptidyl peptidase-4 (DPP-4) inhibitors that aim to enhance the body's ability to lower elevated blood sugar levels.

Another drug in the class, Novartis AG's (NOVN.VX) Galvus, has been delayed by concerns about skin lesions.

The FDA will consider the recommendation on saxagliptin from its expert panel before making its decision, expected by April 30. (Reporting by Susan Heavey, editing by Maureen Bavdek and Tim Dobbyn)

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