FDA approves Invokamet for T2D - Janssen Pharma

The FDA has approved Invokamet (canagliflozin and metformin hydrochloride), from Janssen Pharmaceuticals, in a single tablet, for the treatment of adults with Type 2 Diabetes. The treatment has been studied in six Phase III clinical studies that enrolled 4,732 patients with Type 2 Diabetes.

The studies evaluated Invokana in combination with metformin compared to metformin alone or to metformin plus another diabetes therapy. The studies were part of the comprehensive global Phase III program for Invokana that enrolled 10,285 patients, one of the largest clinical programs in type 2 diabetes submitted to health authorities to date. The studies showed that the combination lowered blood sugar and, in pre-specified secondary endpoints, was associated with significant reductions in body weight and systolic blood pressure.

In two studies comparing Invokana plus metformin to current standard treatments plus metformin � one studying sitagliptin and the other studying glimepiride � Invokana dosed at 300 mg provided greater reductions in A1C levels and body weight than either comparator. A1C is the percent of red blood cell hemoglobin with glucose attached to it and an indicator of average blood glucose over the previous two to three months. In the two studies, the overall incidence of adverse events was similar with Invokana and the comparators. Results from the Phase III studies showed that the most common adverse events are female genital mycotic (fungal) infections, urinary tract infections and increased urination.