Washington, DC—Some type 2 diabetes (T2D) patients have shied away from using glucagon-like peptide (GLP-1) receptor protein treatment, despite effectiveness in lowering blood glucose, because they were uncomfortable injecting themselves.

Now, they will have another alternative. The FDA recently approved Rybelsus, semaglutide oral tablets to improve control of blood sugar in adult patients with T2D, along with diet and exercise.

Rybelsus, from Novo Nordisk, is the first GLP-1 receptor protein treatment approved for use in the United States that does not need to be injected.

“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, MD, 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.”

GLP-1, a normal body hormone, is often found in insufficient levels in T2D patients. Like the injected GLP-1 agents, Rybelsus slows digestion, prevents the liver from making too much sugar, and helps the pancreas produce more insulin when needed.

The FDA reports that efficacy and safety of Rybelsus in reducing blood sugar in patients with T2D diabetes were studied in several clinical trials, two of which were placebo-controlled and several of which were compared with other GLP-1 injection treatments.

Rybelsus was studied both as a stand-alone therapy and in combination with other T2D treatments, including metformin, sulfonylureas (insulin secretagogues), sodium-glucose cotransporter-2 (SGLT-2) inhibitors, insulins, and thiazolidinediones.

Results of the placebo-controlled studies indicate that Rybelsus as a stand-alone therapy resulted in a significant reduction in HbA1c compared with placebo. 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.

Prescribing information for Rybelsus includes a boxed warning to advise healthcare professionals and patients about the potential increased risk of thyroid C-cell tumors. Patients who have ever had medullary thyroid carcinoma or who have a family member who has ever had MTC are advised not to use Rybelsus. In addition, patients who have ever had multiple endocrine neoplasia syndrome type 2 are advised not to use the drug.

The warnings also include information about pancreatitis, diabetic retinopathy, hypoglycemia, acute kidney injury, and hypersensitivity reactions. The risk of hypoglycemia increased when Rybelsus was used in combination with sulfonylureas or insulin, federal regulators explained.

The FDA said it is not known whether Rybelsus can be used by patients who have had pancreatitis.

Rybelsus, which is not recommended as the first choice for treating T2D, is not for use in patients with type 1 diabetes or those with diabetic ketoacidosis.

The oral GLP-1 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. Because Rybelsus slows digestion, patients are urged to discuss other medications they are taking with their healthcare provider before starting the drug. Nausea, diarrhea, vomiting, decreased appetite, indigestion, and constipation are the most common side effects.

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