“FDA Approves First Oral GLP-1 Treatment for Type 2 Diabetes”, 2019-09-20 (; similar):
The US Food and Drug Administration 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.
“Patients want effective treatment options for diabetes that are as minimally intrusive on their lives as possible, and the FDA welcomes the advancement of new therapeutic options that can make it easier for patients to control their condition”, said Lisa Yanoff, M.D, acting director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “Before this approval, patients did not have an oral GLP1 option to treat their type 2 diabetes, and now patients will have a new option for treating type 2 diabetes without injections.”
Type 2 diabetes is the most common form of diabetes, occurring when the pancreas cannot make enough insulin to keep blood sugar at normal levels. GLP-1, which is a normal body hormone, is often found in insufficient levels in type 2 diabetes patients. Like GLP-1, Rybelsus slows digestion, prevents the liver from making too much sugar, and helps the pancreas produce more insulin when needed.
The efficacy and safety of Rybelsus in reducing blood sugar in patients with type 2 diabetes were studied in several clinical trials, 2 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 (SGLT-2) inhibitors, insulins and thiazolidinediones, all in patients with type 2 diabetes.
In the placebo-controlled studies, Rybelsus as a stand-alone therapy resulted in a statistically-significant reduction in blood sugar (hemoglobin A1c) compared with placebo, as determined through HbA1c tests, which measure average levels of blood sugar over time. After 26 weeks, 69% of those taking 7 mg once daily and 77% of those taking 14 mg once daily of Rybelsus decreased their HbA1c to lower than 7%, compared with 31% of patients on placebo.