Regulators in the USA have given the green light to Johnson & Johnson’s new diabetes combo Invokamet.
The US Food and Drug Administration has approved Invokamet, a fixed-dose therapy combining Invokana (canagliflozin) and metformin. The former, a member of the new class of drugs known as sodium glucose co-transporter 2 (SGLT2) inhibitors, was approved in the USA as a single agent in March last year.
The thumbs-up is based on Phase III studies which showed that the combo lowered blood sugar and reduced secondary endpoints of body weight and systolic blood pressure to a greater degree than metformin alone. Invokamet is the first fixed–dose combination of an SGLT2 inhibitor with metformin to be approved in the USA and is available at two doses (50mg/500mg or 150mg/1000 mg, to be taken twice daily.
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.
Jimmy Ren, head of metabolics medical affairs at J&J’s Janssen Pharmaceuticals unit, said that the two doses 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”. As for Invokana, it is the number–one branded non–insulin type 2 diabetes medication newly prescribed by US endocrinologists and since its launch, more than one million prescriptions have been written.
The combo was approved in Europe in April, where it is marketed as Vokanamet.
