Therapy Areas: Diabetes
Novo Nordisk receives marketing authorisation for Ozempic from European Commission
13 February 2018 -

Denmark-based Novo Nordisk has received marketing authorisation from the European Commission for its Ozempic (semaglutide), it was reported yesterday.

The product is intended for the treatment of adults with type two diabetes. It is a new once-weekly analogue of human glucagon-like peptide-1 indicated as monotherapy when metformin is considered inappropriate due to intolerance or is contraindicated, and as an addition to other medicinal products for the treatment of diabetes. The marketing authorisation applies to all 28 European Union member states.

The label is claimed to indicate the superior and sustained reductions in HbA1c and body weight achieved with Ozempic relative to comparator treatments, cardiovascular benefits and the statistically significant decrease in diabetic nephropathy with Ozempic relative to standard of care.