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FDA Delays Decision on Diabetes Treatment Onglyza

Thu, 04/23/2009 - 6:54am
NEW YORK (AP) — Drugmakers Bristol-Myers Squibb Co. and AstraZeneca PLC said Thursday federal regulators need more time to review their application for the diabetes treatment Onglyza. The Food and Drug Administration has extended its deadline for making a decision on the drug by three months, pushing it back to July 30 from April 30. Earlier this month, an FDA panel said the drug appears free from heart problems seen with similar drugs but added that long-term studies should be done after approval to confirm its safety. The FDA is not required to follow the group's recommendation, though it normally does. The drug treats type 2 diabetes and, if approved, will compete with Merck & Co.'s blockbuster Januvia, which had sales of $1.4 billion last year. Analysts have estimated Onglyza's annual sales to be anywhere from $300 million annually to over $1 billion if approved. New York-based Bristol-Myers and London-based AstraZeneca submitted their new drug application June 30. The companies said in a statement they continue to work closely with the FDA. They were encouraged by the advisory panel's recommendation, and they "remain confident in the comprehensiveness of our overall development program and submission" for Onglyza. Bristol-Myers shares rose 3 cents to $19.84 in morning trading Thursday. AstraZeneca shares, meanwhile, were down 3 cents to $33.37.
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