Janssen Pharmaceuticals' fixed-dose therapy for type II diabetes, Invokamet, has been approved by the US Food and Drug Administration.
Invokamet is a combination of Invokana (canagliflozin) sodium glucose co-transporter 2 (SGLT2) inhibitor and metformin.
According to the company, the drug is the first fixed-dose combination of an SGLT2 inhibitor with metformin approved in the US.
Invokamet is an adjunct to diet and exercise that improves glycemic control in adults with type II diabetes mellitus. It is administered to patients for whom treatment with either canagliflozin or metformin is not adequate.
Diabetes Nation medical director Richard Aguilar said: "Invokamet combines, in one tablet, two complementary therapeutic approaches proven effective for managing type II diabetes.
"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."
The drug is not suitable for patients with type I diabetes or for the treatment of diabetic ketoacidosis.
Invokamet will be available in tablets containing canagliflozin 50mgor 150mg, and metformin 500mg or 1000mg.
The Invokana and metformin combination has been studied in six Phase III clinical studies which compared it with metformin alone or with metformin plus another diabetes therapy.
Approximately 4,732 patients with type II diabetes were enrolled for the trials.
The results showed that the combination lowered blood sugar and helped in significant reductions in body weight and systolic blood pressure.
The adverse effects of Invokana are female genital mycotic (fungal) infections, urinary tract infections and increased urination. Adverse effects of metformin are diarrhea, nausea / vomiting, flatulence, asthenia, indigestion, abdominal discomfort and headache.
Janssen Pharmaceuticals metabolics, medical affairs therapeutic area lead Jimmy Ren said: "The available doses of Invokamet allow physicians to tailor therapy for individual patient needs and offer an alternative for patients who may be able to reduce the number of tablets they take each day."