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EU Approves Novo Nordisk's Rybelsus To Treat Type 2 Diabetes

Novo Nordisk said that the European Commission has granted marketing authorisation for Rybelsus for the treatment of adults with insufficiently controlled type 2 diabetes to improve glycaemic control as an adjunct to diet and exercise.

The marketing authorisation applies to all 27 European Union member states and the United Kingdom.

The company expects to launch Rybelsus in the EU countries in the second half of 2020.

Rybelsus is approved in the US, Switzerland and EU as an adjunct to diet and exercise to improve glycemic 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.

Rybelsus is currently under review by several regulatory agencies, including the Japanese Pharmaceuticals and Medical Devices Agency.

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