FDA Approves First Oral GLP-1 For Type 2 Diabetes

The FDA has approved Rybelsus (semaglutide) oral tablets for the improvement of blood sugar control in adults with type 2 diabetes, to be used in combination with diet and exercise. The drug is the first glucagon-like peptide (GLP-1) receptor protein treatment approved in the US that is not given via injection.

The safety and efficacy of Rybelsus was examined in several clinical trials comparing it to either GLP-1 injection treatments or to placebo. It was also studied as a stand-alone treatment and in combination with other treatments, including metformin, sulfonylureas (insulin secretagogues), sodium-glucose co-transporter-2 inhibitors, insulins and thiazolidinediones.

In the placebo-controlled studies, the drug was associated with significant reductions in blood sugar compared with placebo when used as a stand-alone therapy.

The drug comes with a boxed warning of potential risk of thyroid c-cell tumors and that Rybelsus is not recommended as the first choice for treating diabetes. It also includes warnings regarding pancreatitis, diabetic retinopathy, hypoglycemia, acute kidney injury, and hypersensitivity reactions. The most common side effects include nausea, diarrhea, vomiting, decreased appetite, indigestion, and constipation.

—Michael Potts

Reference:

FDA approves first oral GLP-1 treatment for type 2 diabetes [press release]. September 20, 2019. https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-glp-1-treatment-type-2-diabetes.