The Food and Drug Administration has granted marketing approval to Janssen Pharmaceuticals, Inc., for Invokamet, a fixed-dose combination of canagliflozin and metformin.
The drug combines, in a single table, 2 complementary therapies proven effect for managing type 2 diabetes, Richard Aguilar, MD, medical director of Diabetes Nation, said in a press release. “Canagliflozin works with the kidney to promote the loss of glucose in the urine, whereas metformin decreases the production of glucose in the liver and improves the body’s response to insulin.”
Invokamet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes who are not adequately controlled by treatment that includes either canagliflozin or metformin or who are already being treated with both drugs separately.
The product will be available in tablets containing canagliflozin 50 mg or 150 mg and metformin 500 mg or 1,000 mg. The recommended dosing is twice daily. The prescribing information has a boxed warning for lactic acidosis.
Results from the phase 3 studies showed that the most common adverse events with Invokamet are female genital fungal infections, urinary tract infections, and increased urination. These specific AEs generally were mild to moderate in intensity and infrequently led to discontinuation, according to Janssen.