Bristol-Myers and AstraZeneca’s Onglyza wins positive review from FDA panel

Bristol-Myers Squibb and AstraZeneca have reported that the FDA’s endocrinologic and metabolic drugs advisory committee determined that the data supporting the new drug application for Onglyza for the treatment of adults with type 2 diabetes were sufficient to rule out unacceptable cardiovascular risk relative to comparators in the program.

The committee unanimously recommended that the sponsors perform a post-marketing trial to confirm the cardiovascular profile of Onglyza.

Bristol-Myers Squibb and AstraZeneca are working on a series of Phase IIIb and IV studies, including a large, controlled, randomized, post-marketing trial, to further characterize the long-term clinical effectiveness as well as the cardiovascular profile of Onglyza. The companies will now work with the FDA to finalize the post-marketing trial design.

The FDA’s endocrinologic and metabolic drugs advisory committee based its recommendation on review of data from the comprehensive Onglyza clinical development program, which included more than 5,000 individuals, more than 4,000 of whom were given Onglyza, said Bristol-Myers Squibb.

Data presented included safety and efficacy results from six pivotal Phase III trials, in addition to comprehensive post hoc pooled analyses evaluating cardiovascular risk in the Phase IIb and Phase III studies, which included individuals followed for up to 2.5 years and more than 3,700 person-years of exposure to Onglyza. The post hoc pooled analyses did not show evidence of a cardiovascular safety signal in individuals taking Onglyza, the two companies said.