FDA Extends Review Timeline for Onglyza/Saxagliptin by 90 Days

U.S. regulators need more time to review a new diabetes drug from AstraZeneca and Bristol-Myers Squibb Co., delaying by three months a decision on whether the product should be approved. The target deadline is July 30, 2009.

AstraZeneca and Bristol-Myers hope their product, which won backing from a U.S. advisory panel earlier this month, will carve out substantial sales by competing against Merck & Co. Inc.'s blockbuster 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 DPP-4 inhibitors.

The delay was no great surprise, given a trial is underway in patients with kidney damage to rule out the possibility of skin-related side effects -- a problem that prevented Novartis AG's DPP-4 drug Galvus from winning FDA approval.

A spokesman for Bristol-Myers, however, said he was not aware of the FDA asking for any additional information or analysis about Onglyza.

The FDA's advisory panel concluded on April 1 that Onglyza posed no excessive heart risk and could be a promising treatment, but said more data would be needed after approval to weigh any possible long-term risks.

Regulators have paid much greater attention to the heart safety of drugs addressing the $6 billion diabetes market after researchers linked GlaxoSmithKline Plc.'s diabetes pill Avandia to greater heart risks in 2007.