Briefing Summary: US FDA Posts Advisory Committee Materials About Results of the CV Outcomes Trials for Saxagliptin and Alogliptin – APR 14, 2015 (EMDAC)
The US FDA has posted details, including company and FDA Briefing Materials, for the Tuesday, April 14, 2015 Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting. In the morning session, the committee will discuss the results of the cardiovascular outcomes trial (CVOT), Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR), for new drug application (NDA) 22350, Onglyza (saxagliptin) and NDA 200678, Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets manufactured/marketed by AstraZeneca AB.
During the afternoon session, the committee will discuss the results of the CVOT, Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care (EXAMINE), for NDA 22271, Nesina (alogliptin); NDA 022426, Oseni (alogliptin and pioglitazone); and NDA 203414, Kazano (alogliptin and metformin) tablets marketed by Takeda Pharmaceuticals U.S.A., Inc. (Takeda).