FDA Approves Rybelsus for First-line Treatment of Diabetes

This update removes a previous limitation that it could not be used as the first therapy.

The FDA has approved a label update for Novo Nordisk’s Rybelsus (semaglutide) for use as a first-line treatment option for adults with type 2 diabetes. This update removes a previous limitation that it could not be used as the first therapy. Initially approved by the FDA in 2019, Rybelsus is the first and only GLP-1 analog in pill form and is indicated to improve glycemic control for adults with type 2 diabetes.

Rybelsus works to lower blood sugar in three ways: by increasing the release of insulin from the pancreas when blood sugar is high, decreasing the release of sugar from the liver, and slowing the process of food leaving the stomach after eating. Rybelsus comprises a unique co-formulation of semaglutide and an absorption enhancer called SNAC, which facilitates absorption of semaglutide in the stomach, making it possible to provide semaglutide as a pill.

The wholesale acquisition cost of Rybelsus is $935.77 for 30 tablets for either the 7 mg or 14 mg dose. The company indicates Rybelsus has commercial coverage of about 99%, including the top five plans.

Many commercial insurers offer Rybelsus for a $25 copay, but the company indicated in its press release that some commercially insured patients may pay as little as $10 for a one- to three-month prescription with copay assistance.