Novo Nordisk announced Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Rybelsus (semaglutide) for the treatment of adults with insufficiently controlled type 2 diabetes to improve glycaemic control as an adjunct to diet and exercise. The regulator noted that the drug is the first GLP-1 receptor agonist treatment developed for oral use.
Specifically, the CHMP recommended that Rybelsus be authorised as monotherapy when metformin is considered inappropriate, as well as in combination with other medicinal products for the treatment of type 2 diabetes. Novo Nordisk added that the drug's 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.
Mads Krogsgaard Thomsen, chief science officer at Novo Nordisk, said "we believe [Rybelsus] has the potential to set a new standard for the treatment of type 2 diabetes in the EU." The drug gained US approval last September as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes.
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