A diabetes medicine from pharmaceutical firm Bristol-Myers Squibb has passed initial tests into possible heart problems but needs more study before full approval can be given, the US drug watchdog has said.
Bristol-Myers and partner AstraZeneca are hoping Onglyza will be approved for the treatment of people suffering from type 2 diabetes.
The drug is the first to go before the Food and Drug Administration’s (FDA’s) panel of diabetes experts since the organisation issued new safety guidelines for diabetes treatments last year amid concerns over heightened risks of heart attack with GlaxoSmithKline’s pill Avandia.
Outside experts making up the panel voted 10 to 2 that the data indicated no risk of heart attack, stroke and other problems.
But the members all said the drug maker should be required to continue studying the treatment in high-risk patients, to assure the drug’s heart-safety.
Panel chairman Dr Kenneth Burman of Washington Hospital Centre, said: “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.”
The FDA normally follows up recommendations from the group, though it is not technically required to do so. A final decision is expected by April 30.
Copyright Press Association 2009