Janssen’s Vokanamet approved in EU for adults with type 2 diabetes

28 April 2014

The European Commission has approved US health care giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen-Cilag’s Vokanamet (a fixed-dose therapy combining canagliflozin and immediate release metformin hydrochloride in a single tablet) in the European Union, for the treatment of adults with type 2 diabetes mellitus to improve glycemic control.

Canagliflozin as a single agent was approvedas Invokana in the EU in November 2013 and in the USA in March of that year. This latest EC decision follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommending the approval of canagliflozin and immediate release metformin hydrochloride fixed dose combination therapy, in February 2014. The combination therapy, which is taken as a single pill twice daily, is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycemic control in:

patients not adequately controlled on their maximally tolerated doses of metformin alone;
patients on their maximally tolerated doses of metformin along with other glucose-lowering medicinal products including insulin, when these do not provide adequate glycemic control; and
patients already being treated with the combination of canagliflozin and metformin as separate tablets.

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