Canagliflozin/Metformin Combo Finally Approved in US

Disclosures

August 11, 2014

The US Food and Drug Administration (FDA) has approved a fixed-dose combination of the sodium glucose cotransporter 2 (SGLT2) inhibitor canagliflozin (Invokana, Janssen Pharmaceuticals) and metformin for the treatment of adults with type 2 diabetes.

The product, Invokamet, is the first combination of an SGLT2 inhibitor with metformin cleared for marketing in the United States.

The 2-drug combo was rejected by the FDA earlier this year, with the agency issuing a complete response letter, requesting additional information to support the comparability of the twice-daily dosing regimen of canagliflozin — as part of the canagliflozin/metformin fixed-dose combination — and once-daily dosing of canagliflozin as a single agent.

"Janssen supplied this information based on available clinical data from the comprehensive phase 3 clinical development program for canagliflozin," a company spokesperson told Medscape Medical News. "The company worked closely with the FDA to address outstanding questions and is pleased with the approval of Invokamet."

Invokamet will be available in tablets containing 50 or 150 mg of canagliflozin and 500 or 1000 mg of metformin. The recommended dosing will be twice daily.

The combination of canagliflozin and metformin is also approved in the European Union as Vokanamet, where it competes with Xigduo (AstraZeneca/Bristol-Myers Squibb), a 2-drug product combining metformin with the SGLT2 inhibitor dapagliflozin (Forxiga, AstraZeneca/Bristol-Myers Squibb).

As well as the United States, canagliflozin as a single agent, dosed once-daily, is approved in Aruba, Australia, Brazil, Canada, Chile, Costa Rica, El Salvador, the  European Union (31 countries), Guatemala, Kuwait, Mexico, Peru, Singapore, South Korea, Switzerland, and United Arab Emirates, Janssen says.

The company adds that Invokana is the number-one branded noninsulin type 2 diabetes medication newly prescribed by US endocrinologists, as of July 25, 2014 (based on data from the IMS NPA market dynamics database). It is also the second most common branded therapy prescribed by primary-care physicians when adding or switching therapies in patients, based on the same data.

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