Takeda announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the Food and Drug Administration (FDA) has met to review the EXAMINE trial, one of the first cardiovascular outcomes trials (CVOT) in patients with type 2 diabetes.
In its 2008 Guidance, the FDA required all type 2 diabetes treatments under development to complete to evaluate cardiovascular (CV) safety. Based on the data from the EXAMINE trial, the Committee voted that the use of alogliptin in patients with type 2 diabetes had an acceptable CV risk profile.
EXAMINE (EXamination of CArdiovascular OutcoMes: AlogliptIN vs. Standard of CarE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome) was a large, randomized, double-blind, placebo-controlled outcomes study that evaluated CV safety following treatment with alogliptin plus standard of care vs. placebo plus standard of care, in patients with type 2 diabetes at high risk for major cardiovascular events (MACE) due to recent acute coronary syndrome (ACS). The study’s primary objective was to assess non-inferiority of CV risk based on a primary composite endpoint of CV death, nonfatal myocardial infarction (MI) and nonfatal stroke.
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Alogliptin is approved for use as monotherapy (Nesina) and also in fixed-dose combination with pioglitazone (Oseni) and metformin HCl (Kazano) for the treatment of type 2 diabetes in adults as adjuncts to diet and exercise.
The Advisory Committee recommendation is non-binding and will be considered by the FDA.
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