Zealand Pharma A/S announces that its partner, Sanofi, has received a positive opinion from the Committee for Medicinal Products for Human Use, or CHMP, under the European Medicines Agency, or EMA, recommending the approval of once-daily Lyxumia, or lixisenatide, for the treatment of adults with Type 2 diabetes to achieve glycaemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control. The CHMP positive opinion will now be forwarded to the European Commission, which has the authority to approve medicines for the European Union. A formal decision by the Commission is expected in the coming months. In addition to the European Union, lixisenatide has been submitted for regulatory approval in 11 countries. Submission of a New Drug Application to the U.S. FDA is planned for December 2012.
- Pharmaceuticals & Drug Trials
- European Medicines Agency
- the European Commission