Posted by Michael Wonder on 04 Feb 2020
Rybelsus (oral semaglutide) recommended for approval for the treatment of adults with type 2 diabetes by the European regulatory authorities
31 January 2020 - Novo Nordisk today announced that the CHMP under the EMA has adopted a positive opinion, recommending marketing authorisation for Rybelsus (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 Rybelsus 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.
