FDA expands indication for Invokamet

The FDA today approved Janssen’s Invokamet as a first-line treatment in adults with type 2 diabetes, according to a company press release.

Invokamet is a combination therapy of the company’s Invokana (canagliflozin) and metformin hydrochloride. The new approval will allow treatment for adults with type 2 diabetes who are not already being treated with canagliflozin or metformin and may benefit from dual therapy.

“Physicians increasingly try to achieve greater initial blood sugar control by using dual therapy at the outset vs. single-agent therapy alone, especially for patients with higher HbA1c levels,” John Anderson, MD, of Frist Clinic in Nashville, Tennessee, said in the release. “Invokamet combines two effective, complementary medicines — canagliflozin and metformin — into one convenient pill, to lower HbA1c significantly more than metformin alone.”

Invokamet was previously approved by the FDA in August 2014 as an adjunct to diet and exercise.

Invokamet is currently available in four dose strengths in tablets containing canagliflozin 500 mg or 150 mg and metformin 500 mg or 1,000 mg. Dosing is recommended at twice per day.

“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,” Paul Burton, MD, PhD, vice president of medical affairs for Janssen, said in the release. “This expansion marks an important milestone as we continue to study Invokamet and Invokana — the No. 1 prescribed SGLT2 inhibitor with more than 8 million prescriptions to date — for the treatment of type 2 diabetes.”