Novel GLP-1 analogue in once-weekly formula receives EU approval as T2DM therapyFeb. 12, 2018 - news
The European Commission has granted marketing authorization for semaglutide for the treatment of adults with type 2 diabetes (T2DM). Semaglutide is a new once-weekly analogue of human glucagon-like peptide-1 (GLP-1) indicated as monotherapy when metformin is considered inappropriate due to intolerance or when it is contraindicated, and as an addition to other medicinal products for the treatment of diabetes. The marketing authorization applies to all 28 European Union member states.
The label reflects the superior and sustained reductions in HbA1c and body weight achieved with semaglutide relative to comparator treatments, cardiovascular benefits and the statistically significant reduction in diabetic nephropathy with semaglutide relative to standard of care. These results were obtained in the SUSTAIN program, a global clinical development program that comprised eight phase 3a trials, encompassing more than 8,000 adults with T2DM. The phase 3a program involved a broad range of people with T2DM, including some with high cardiovascular risk profiles and people with and without renal disease.
Semaglutide has been approved in the EU for use in a multi-dose pen, the latest generation of Novo Nordisk prefilled devices. However, Novo Nordisk intends to submit a variation application to the European Medicines Agency seeking approval of an updated pen offering. The launch of semaglutide is expected to take place in the first EU countries in the second half of 2018 following the approval of the variation application for the updated pen offering.