- The Washington Times - Wednesday, April 1, 2009

SILVER SPRING, MD. (AP) - A federal panel said Wednesday a diabetes drug from Bristol-Myers Squibb appears free from heart problems seen with similar drugs but said long-term studies should be done after approval to confirm its safety.

Bristol-Myers and partner AstraZeneca have asked the Food and Drug Administration to approve their drug Onglyza for millions of Americans with type 2 diabetes. The drug is the first to go before the panel of diabetes experts since the agency issued new safety guidelines for diabetes treatments last year. Concerns about heightened risks of heart attack with GlaxoSmithKline’s blockbuster pill Avandia created a storm for FDA and drugmakers in 2007.

The FDA panel voted 10 to 2 that the companies’ data do not suggest the drug hastens heart attack, stroke and other problems. But panelists voted unanimously that the company should be required to conduct a long-term study in high-risk patients, including the elderly, to assure the drug’s heart safety.

“Our primary goal is to protect the patient, and I just don’t think there’s enough data in the studies to be absolutely certain that there is no risk,” said panel chairman Kenneth Burman of Washington Hospital Center.

The FDA is not required to follow the group’s recommendation, though it normally does. A final decision is expected by April 30.

The two votes provide a mixed picture of the government’s regulatory stance. A requirement for long-term safety studies could significantly drive up research costs for dozens of companies working on treatments to compete in the $5 billion U.S. diabetes drug market.

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