FDA nod for Rybelsus label update

13 January 2023

The US Food and Drug Administration (FDA) has approved a label update for Rybelsus (semaglutide) tablets 7mg or 14mg, allowing use as a first-line treatment option for adults with type 2 diabetes who have not previously taken a diabetes treatment.

News of the amendment pushed shares of the drug’s developer, Danish diabetes care giant Novo Nordisk (NOV: N), up 2.4% to 935.50 kroner.

This update removes a previous limitation of use that stated the medication should not be used as the initial therapy for treating patients with type 2 diabetes. Initially approved by the FDA in 2019, Rybelsus is the first and only GLP-1 analog in pill form and is indicated, along with diet and exercise, to improve glycemic control for adults with type 2 diabetes.

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