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04 Feb 2020
Admin
News Article

Rybelsus recommended for approval for the treatment of adults with type 2 diabetes by the European regulatory authorities

BagsvÃ¦rd, Denmark, 31 January 2020 - Novo Nordisk today announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorisation for RybelsusÂ® (oral semaglutide) for the treatment of adults with insufficiently controlled type 2 diabetes to improve glycaemic control as an adjunct to diet and exercise. The CHMP recommends RybelsusÂ® to be indicated as monotherapy when metformin is considered inappropriate, as well as in combination with other medicinal products for the treatment of type 2 diabetes. The label also refers to clinical trial results with respect to combination with other diabetes medications, effects on glycaemic control, cardiovascular events and the populations studied. â€œWe are very excited about the positive opinion for RybelsusÂ®, as it is the first and only GLP-1 in a tablet, and we believe it has the potential to set a new standard for the treatment of type 2 diabetes in the EU,â€ said Mads Krogsgaard Thomsen, executive vice president and chief science officer. â€œA high proportion of people with type 2 diabetes does not achieve target blood sugar levels, which underpins the need for new and more efficacious solutions to better manage their disease.â€ Novo Nordisk expects to receive final marketing authorisation from the European Commission in the beginning of second quarter of 2020.

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