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Janssen gets FDA's OK for Invokamet
August 11th, 2014
RARITAN, N.J. – Janssen Pharmaceuticals Inc. has been cleared by the Food and Drug Administration to market Invokamet, a combination therapy for adults with type 2 diabetes.
Janssen said late Friday that Invokamet is a fixed-dose therapy that brings together Invokana (canagliflozin) and metformin hydrochloride in a single tablet.
Invokana is the first sodium glucose co-transporter 2 (SGLT2) inhibitor available in the United States, while metformin is commonly prescribed early in the treatment of type 2 diabetes.
Janssen noted that Invokamet marks the first fixed-dose combination of an SGLT2 inhibitor with metformin approved in the United States.
"Invokamet combines, in one tablet, two complementary therapeutic approaches proven effective for managing type 2 diabetes," stated Richard Aguilar, M.D., medical director of Diabetes Nation. "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 canagliflozin and metformin as separate medications.
The medication will be available in tablets containing 50 mg or 150 mg of canagliflozin and 500 mg or 1,000 mg of metformin, according to Janssen. The recommended dosing is twice daily. The prescribing information for Invokamet also contains a boxed warning for lactic acidosis, a rare but serious complication that can occur due to metformin accumulation.
"As with Invokana, Invokamet provides adults with type 2 diabetes an oral therapy that lowers blood sugar and is also associated with reductions in body weight and systolic blood pressure," commented Jimmy Ren, Ph.D., therapeutic area lead in metabolics, in Janssen's medical affairs unit. "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."
Janssen reported that type 2 diabetes comprises 90% to 95% of people with diabetes, and that almost half of adults with type 2 diabetes don't achieve recommended levels of glucose control.