The FDA's Endocrinologic and Metabolic Drugs Advisory Committee has voted in favor of the new drug application for Onglyza from Bristol-Myers Squibb (BMS) and Astrazeneca to treat adults with type 2 diabetes, stating that the data were sufficient to rule out unacceptable cardiovascular risk relative to comparators in the program.
However, panelists unanimously voted that the companies should be required to conduct a long-term study in high-risk patients, including the elderly, to assure the drug's heart safety, the Associated Press reported. The two votes provide a mixed picture of the government's regulatory stance.
The new drug application for Onglyza (saxagliptin) was submitted to the FDA on June 30, 2008, and has an action date of April 30.
Onglyza is a selective, reversible inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. The investigational drug, developed under joint development by BMS and AstraZeneca, was designed to be a selective inhibitor with extended binding to the DPP-4 enzyme, with dual routes of clearance. DPP-4 inhibitors are a class of compounds that affect the action of natural hormones in the body called incretins.
The companies said the 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. Data presented included safety and efficacy results from six pivotal Phase III trials, in addition to 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.