Results Wire: US FDA Advisory Committee Supports Adding Cardiovascular Safety Information to the Labeling for Saxagliptin and Alogliptin – APR 14, 2015 (EMDAC)
On Tuesday, April 14, 2015, during the morning session, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) discussed the results of the SAVOR cardiovascular outcomes trial (CVOT), for Onglyza (saxagliptin) and Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets manufactured/marketed by AstraZeneca AB (AstraZeneca). A majority of the Committee, 13 of 15 members, voted that the results of SAVOR demonstrate that the use of saxagliptin in patients with type 2 diabetes has an acceptable cardiovascular (CV) risk profile. A majority of the Committee, 14 of 15 members, voted to add new safety information to the label.
During the afternoon session, the Committee discussed the results of the EXAMINE CVOT for Nesina (alogliptin); Oseni (alogliptin and pioglitazone); and, Kazano (alogliptin and metformin) tablets marketed by Takeda Pharmaceuticals U.S.A., Inc. (Takeda). The Committee voted unanimously (16 of 16 members) that the results of EXAMINE demonstrate that the use of alogliptin in patients with type 2 diabetes has an acceptable CV risk profile. A majority of the Committee, 13 of 16 members, voted to add new safety information to the label.