FDA panel backs safety of B-MS/AZ' Onglyza
An expert panel convened by the US Food and Drug Administration has voted 10 to two that data on type 2 diabetes drug Onglyza (saxagliptin) demonstrates an acceptable cardiovascular risk relative to comparators.
The potential blockbuster is being developed by US drug major Bristol-Myers Squibb and Anglo-Swedish pharmaceutical group AstraZeneca. The FDA panel unanimously recommended that the sponsors perform a post-marketing trial to confirm the cardiovascular profile of the agent. The companies are in the process of finalizing its design.
Onglyza is a reversible inhibitor of the dipeptidyl peptidase-4 enzyme. If approved, it will rival the first and only DPP-4 blocker on the market, US drug major Merck & Co's Januvia (sitagliptin), which earned $1.4 billion last year worldwide.
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