FDA Approves Sanofi’s Basal Insulin Toujeo

Sanofi has received approval from the US Food and Drug Administration (FDA) for Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL), a once-daily long-acting basal insulin, to improve glycemic control in adults living with Type 1 and Type 2 diabetes. Toujeo is expected to be available in the US at the beginning of the second quarter of 2015.

Sanofi also reports the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL). The European Commission (EC) is expected to make a final decision on granting marketing authorization for Toujeo in the European Unionin the coming months.

Once approved, Toujeo will be available in the Toujeo SoloSTAR, a disposable prefilled pen which contains 450 insulin units (IU), and it has a maximum single injection dose of 80 IU.

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) and now faces patent expiry, effective in February 2015 in the US and in May 2015 in the EU. 

Eli Lilly also developed a new basal insulin, insulin peglispro and plans to submit for regulatory filings later in 2016. The likely to occur after 2016. Lilly company had initially targeted filings for 2015 but earlier this year, reported that it would delay filings and did not specify an exact time, but said it was likely to occur after 2016.

Source: Sanofi (US approval) and Sanofi (EU recommendation)

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