Last Updated: 2009-04-01 16:48:47 -0400 (Reuters Health)

SILVER SPRING, Maryland (Reuters) - Bristol-Myers Squibb Co and AstraZeneca Plc's experimental diabetes pill poses no excessive heart risk and could be a promising treatment, a U.S. advisory panel ruled on Wednesday.

But the Food and Drug Administration's panel of outside experts also said more data would be needed after approval to weigh any possible long-term risks, especially in older patients and others more likely to have heart problems.

"This might wind up being a great drug, but we don't know that yet," said panelist Marvin Konstam, a cardiologist at Tufts University School of Medicine.

The companies are hoping to market the drug under the brand Onglyza to compete against Merck & Co Inc's blockbuster drug Januvia. Both drugs aim to enhance the body's ability to lower elevated blood sugar levels and are part of a class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors.

All but two of the 12 panelists said the companies' drug, also known as saxagliptin, did not cause an unacceptable number of strokes, heart attacks or other heart problems.

But several members expressed concern that, if approved, the FDA should require information on the drug's label, noting the lack of information for patients already at risk for heart trouble, including the elderly.

In a 12-0 vote, the panel said the agency should require further study of saxagliptin, even if it wins approval.

FDA officials will consider the panel's recommendation before deciding whether to approve the product. The companies expect a decision by April 30.

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