The Food and Administration (FDA) has approved updated labeling for Rybelsus® (semaglutide) 7mg and 14mg tablets allowing use as a first-line treatment option for adults with type 2 diabetes. 

Rybelsus is a glucagon-like peptide (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. In 2019, the treatment was approved as the first GLP-1 analog in pill form. The approval was based on results from 10 clinical trials that compared the safety and efficacy of Rybelsus with placebo, empagliflozin, sitagliptin, and liraglutide in over 9000 patients with type 2 diabetes.

The labeling for Rybelsus has now been updated removing a previous limitation of use that stated the medication was not recommended as first-line therapy for patients inadequately controlled on diet and exercise. 

Rybelsus is supplied as 3mg, 7mg, and 14mg strength tablets in 30-count bottles. 

References

  1. Novo Nordisk announces FDA approval of label update for Rybelsus® (semaglutide) allowing use as a first-line option for adults with type 2 diabetes. News release. Novo Nordisk. Accessed January 13, 2023. https://www.prnewswire.com/news-releases/novo-nordisk-announces-fda-approval-of-label-update-for-rybelsus-semaglutide-allowing-use-as-a-first-line-option-for-adults-with-type-2-diabetes-301720965.html.
  2. Rybelsus. Package insert. Novo Nordisk; 2022. Accessed January 13, 2023. https://www.novo-pi.com/rybelsus.pdf.