Global health care company Novo Nordisk A/S (CPH:NOVOB) announced on Friday the adoption of a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA), 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.

Reportedly, the CHMP has recommended that 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.

According to the company, Rybelsus is the first and only GLP-1 in a tablet and believes it has the potential to set a new standard for the treatment of type 2 diabetes in the EU.

Novo Nordisk expects to receive final marketing authorisation from the European Commission in the beginning of second quarter of 2020.