FRIDAY, Sept. 20, 2019 (HealthDay News) -- The U.S. Food and Drug Administration approved Rybelsus (semaglutide) oral tablets, the first noninjectable glucagon-like peptide receptor protein treatment to be approved in the United States, the agency announced today.
Rybelsus is approved in 7-mg and 14-mg doses to improve blood sugar control in adults with type 2 diabetes in addition to diet and exercise. The drug is to be taken with no more than 4 oz of plain water 30 minutes before an individual's first food, beverage, or other oral medication of the day.
Approval was based on efficacy and safety data from several PIONEER clinical trials that included 9,543 participants. In two placebo-controlled trials, Rybelsus alone demonstrated a significant reduction in hemoglobin A1c compared with placebo. At 26 weeks, 69 and 77 percent of patients taking 7 mg and 14 mg, respectively, of Rybelsus once daily saw a decrease in hemoglobin A1c to less than 7 percent versus 31 percent of patients taking placebo. The most commonly reported side effects with Rybelsus included nausea, diarrhea, vomiting, decreased appetite, indigestion, and constipation.
A Boxed Warning on the prescribing information for Rybelsus advises about a potential increased risk for thyroid c-cell tumors. The prescribing information also indicates that Rybelsus is not recommended as front-line therapy for treating diabetes. The drug is contraindicated in patients who have had medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia as well as patients with a family history of MTC. Rybelsus is not indicated for use in type 1 diabetes or in patients with diabetic ketoacidosis. The prescribing information also warns of pancreatitis, diabetic retinopathy, hypoglycemia, acute kidney injury, and hypersensitivity reactions with Rybelsus. The FDA notes that the risk for hypoglycemia increased with Rybelsus when it was used with sulfonylureas or insulin.
Approval was granted to Novo Nordisk.