The US FDA has scheduled an Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) Meeting for Tuesday, April 14, 2015.
During 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, 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, for NDA 22271, Nesina (ALOGLIPTIN); NDA 022426, Oseni (ALOGLIPTIN and PIOGLITAZONE); and NDA 203414, Kazano (ALOGLIPTIN and METF ORMIN) tablets marketed by Takeda Pharmaceutical U.S.A., Inc. Saxagliptin and ALOGLIPTIN are dipeptidyl peptidase-4 inhibitors, both indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Both CVOTs were submitted in accordance with the 2008 FDA Draft Guidance, “Diabetes Mellitus--Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes,” to demonstrate that a new antidiabetic therapy to treat type 2 diabetes is not associated with an unacceptable increase in cardiovascular risk.