The FDA panel voted 10 to 2 in favor of the drug and concluded that the companies’ data do not suggest that the drug increases risk for heart attack, stroke and other problems.

 

However, the panelists said the companies should 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.

 

Onglyza is taken as a once-daily table to treat high blood sugar in type 2 diabetes. Its producers want to market the drug as a competitor against Merck & Co Inc’s blockbuster drug Januvia. Both drugs belong to a class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors.

 

Bristol and AstraZeneca are seeking approval for Onglyza as a standalone drug as an adjunct to diet and exercise, and in combination with other diabetes drugs. 

 

A final decision on the drug is to be taken by the FDA on April 30.