20 September 2019 - The U.S. FDA today approved Rybelsus (semaglutide) oral tablets to improve control of blood sugar in adult patients with type 2 diabetes, along with diet and exercise.
Rybelsus is the first glucagon-like peptide (GLP-1) receptor protein treatment approved for use in the United States that does not need to be injected. GLP-1 drugs are non-insulin treatments for people with type 2 diabetes.
The efficacy and safety of Rybelsus in reducing blood sugar in patients with type 2 diabetes were studied in several clinical trials, two of which were placebo-controlled and several of which were compared to other GLP-1 injection treatments. Rybelsus was studied as a stand-alone therapy and in combination with other diabetes treatments, including metformin, sulfonylureas (insulin secretagogues), sodium-glucose co-transporter-2 inhibitors, insulins and thiazolidinediones, all in patients with type 2 diabetes.