Zealand Pharma Announces That Once-Daily Lyxumia® 1 (lixisenatide) Has Received CHMP Positive Opinion for the Treatment of Adults With Type 2 Diabetes in the EU
Published: Nov 16, 2012
Copenhagen, 16 November 2012 – Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL) announces that its partner, Sanofi (EURONEXT: SAN and NYSE: SNY), has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA), recommending the approval of once-daily Lyxumia® (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.