US FDA accepts Sanofi's NDA for diabetes drug lixisenatide

19 February 2013

The US Food and Drug Administration has accepted for review French drug major Sanofi’s (Euronext: SAN) New Drug Application for lixisenatide, the first once-daily prandial GLP-1 receptor agonist for the treatment of adults with type 2 diabetes mellitus, the company announced this morning.

The acceptance of the lixisenatide NDA filing follows this month’s European Commission approval of lixisenatide - under the trade name Lyxumia - in the European Union (The Pharma Letter February 4). Eric Le Berrigaud, an analyst at Bryan Garnier & Co in Paris, believes Lyxumia could generate sales of $1.4 billion by 2020. The US trade name for the drug is still under consideration.

Clinical backing

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