FDA approves first oral GLP-1 treatment for type 2 diabetes
The U.S. 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.
The prescribing information for Rybelsus includes a boxed warning to advise health care professionals and patients about the potential increased risk of thyroid c-cell tumors, and that Rybelsus is not recommended as the first choice of medicine for treating diabetes. Patients who have ever had medullary thyroid carcinoma (MTC) or who have a family member who has ever had MTC are advised not to use Rybelsus. Additionally, patients who have ever had an endocrine system condition called multiple endocrine neoplasia syndrome type 2 (MEN 2) are advised not to use Rybelsus. Rybelsus is not for use in patients with type 1 diabetes and people with diabetic ketoacidosis.
Rybelsus also has warnings about pancreatitis (inflammation of the pancreas), diabetic retinopathy (damage to the eye’s retina), hypoglycemia (low blood sugar), acute kidney injury and hypersensitivity reactions. It is not known whether Rybelsus can be used by patients who have had pancreatitis. The risk of hypoglycemia increased when Rybelsus was used in combination with sulfonylureas or insulin.
Rybelsus should be taken at least 30 minutes before the first food, beverage or other oral medication of the day, with no more than 4 ounces of plain water. Rybelsus slows digestion, so patients should discuss other medications they are taking with their health care provider before starting Rybelsus. The most common side effects are nausea, diarrhea, vomiting, decreased appetite, indigestion and constipation.
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