Japan Approves Sanofi’s New Basal InsulinBy
Sanofi reports that the Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing authorization for insulin glargine [rDNA origin] injection, 300 U/mL, a basal insulin for treating Type 1 and Type 2 diabetes mellitus, where treatment with insulin is needed. Known as Toujeo in the US and Europe, the new insulin treatment will be available in Japan under the trade name Lantus XR.
Toujeo was previously approved by the US Food and Drug Administration, the European Commission, and Health Canada, and is under review by other regulatory authorities around the world. Toujeo is now available in the US, Germany, Denmark, and the Netherlands and has been registered in Australia. The product will become available in other countries in the coming months.
Toujeo is a next-generation, once-daily basal insulin based on a broadly used molecule (insulin glargine), which is the active ingredient in Sanofi’s best-selling product, Lantus. Lantus had 2014 sales of EUR 6.344 billion ($7.180 billion) which faces patent expiry, effective in February 2015 in the US and in May 2015 in the European Union.