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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.
'We are very excited about the positive opinion for Rybelsus, 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,' said
About Rybelsus
Rybelsus (oral semaglutide) is an analogue of the naturally occurring hormone GLP-1, and it is the world's first and only GLP-1 in a tablet. Rybelsus is approved in the US and it is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes. It is administered once daily and is approved for use in two therapeutic dosages, 7 mg and 14 mg in the US.
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