Cardiovascular Risk Profile of Diabetes Drug Acceptable
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.