Onglyza (saxagliptin), an investigational diabetes drug under joint development by Bristol-Myers Squibb and AstraZeneca, has a cardiovascular risk profile acceptable to the FDA’s Endocrinology and Metabolic Drugs Advisory Committee, according to a press release issued by the companies.
A New Drug Application for Onglyza as a treatment for type 2 diabetes in adults was submitted to the FDA on June 30, 2008. The committee unanimously recommended that Bristol-Myers Squibb and AstraZeneca perform a post-marketing trial to confirm the cardiovascular profile of the drug.
The companies are working on a series of phase IIIb and IV studies. Onglyza is a selective, reversible inhibitor of the dipeptidyl peptidase-4 enzyme.