Janssen’s Invokamet gets expanded indication from FDA

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday approved an expanded indication for Janssen Pharmaceuticals’ diabetes medication Invokamet (canagliflozin and metformin HCl). The drug has been approved as a first-line treatment for adults with type 2 diabetes who aren’t being treated with either canagliflozin or metformin. 

 

The drug had initially been approved as adjunct to diet and exercise to control blood glucose levels that wasn’t being controlled adequately by either of Invokamet’s ingredients alone, or who were being treated with both medications separately. 

 

Invokamet is available in 50-, 150-, 500- and 1000-mg dosage strengths. The drug contains a boxed warning for lactic acidosis, which is a rare occurrence of metformin accumulation. 

 

“The available doses of Invokamet allow physicians to tailor therapy for individual patient needs and offer an alternative for people living with type 2 diabetes who may be able to reduce the number of pills they take each day,” Janssen VP medical affairs Dr. Paul Burton said. “This expansion marks an important milestone as we continue to study Invokamet and Invokana ... for the treatment of type 2 diabetes.”