By JENNIFER CORBETT DOOREN
WASHINGTON -- The Food and Drug Administration extended the review of a proposed diabetes drug being developed by Bristol-Myers Squibb Co. and AstraZeneca PLC until July 30, the companies said Thursday.
The companies said the FDA needed more time to review the drug, saxagliptin. The agency had an original deadline of April 30. If approved, saxagliptin would be sold under the brand name Onglyza.
"The companies continue to work closely with the FDA to support the review of Onglyza," Bristol-Myers and AstraZeneca said in a joint statement.
Earlier this month the drug went before an outside panel of medical experts that was asked to look at whether the drug carried excess cardiovascular risk. The panel voted 10 to 2 in saying clinical studies submitted showed the drug didn't carry excess risk, which amounted to a recommendation that the FDA approve the drug.
The FDA has been concerned about cardiovascular side effects since a research paper was published in 2007 linking GlaxoSmithKline PLC's widely used Avandia to increased risk of heart attack. In December the agency issued new guidance requiring drug makers to conduct more stringent clinical trials for Type-2 diabetes drugs to better assess heart-attack and stroke risks.
Saxagliptin is a DPP-4 inhibitor, which is designed to work by increasing the level of so-called incretin hormones in the body that help lower blood-glucose levels. So far the only DPP-4 drug on the U.S. market is Merck & Co.'s Januvia.
About 23 million Americans have Type 2 diabetes, a disease characterized by high blood-glucose levels that result from the body's inability to use insulin. The disease raises the risk of cardiovascular, kidney and other health problems.
Write to Jennifer Corbett Dooren at jennifer.corbett-dooren@dowjones.com
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