By Steven Reinberg
"Before this approval, patients did not have an oral GLP-1 option to treat their type 2 diabetes, and now patients will have a new option for treating type 2 diabetes without injections," said Dr. Lisa Yanoff in an agency news release. She is acting director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research.
GLP-1 is a hormone often found in low levels in people with type 2 diabetes. Rybelsus acts by slowing digestion and preventing the liver from making too much sugar, which helps the pancreas produce more insulin.
In clinical trials, Rybelsus significantly lowered blood sugar.
After 26 weeks, 77% of patients taking 14 mg of Rybelsus daily saw their HbA1C drop below 7% compared with 31% among those receiving a placebo. HbA1C is a measure of blood sugar.
Rybelsus, made by the pharmaceutical company Novo Nordisk, is not recommended as the first choice for treating diabetes, the FDA said.
The drug has potential risks. It may cause certain thyroid tumors. Patients who have had thyroid cancer or have a relative who has had it are advised not to take Rybelsus.
Rybelsus is also not for people with type 1 diabetes or diabetic ketoacidosis. The drug label also warns about inflammation of the pancreas, vision loss, low blood sugar and kidney injury.
The most common side effects are nausea, diarrhea, vomiting, decreased appetite, indigestion and constipation, the FDA noted.