The FDA has granted approval of semaglutide oral tablets (Rybelsus, Novo Nordisk) 7 mg or 14 mg. The drug is the first oral glucagon-like peptide (GLP-1) receptor protein treatment for type 2 diabetes to receive the agency’s approval.
Along with diet and exercise, semaglutide oral tablets are indicated to improve control of blood sugar in adult patients. GLP-1 drugs are noninsulin treatments for patients with type 2 diabetes.2
“GLP-1 receptor agonists are effective medications for people with type 2 diabetes but have been underutilized in part because they have, until now, only been available as an injectable treatment,” said Vanita R. Aroda, MD, Director of Diabetes Clinical Research at Brigham and Women’s Hospital in Boston, in a prepared statement.2
The efficacy and safety of the drug in reducing blood sugar were studied in 10 PIONEER clinical trials,2 2 of which were placebo-controlled and several of which were compared to other GLP-1 injection treatments.1 In the 9543 enrolled participants, the drug was studied as a stand-alone therapy and in combination with other therapies, including metformin, sulfonylureas, sodium-glucose co-transporter-2 inhibitors, insulins, and thiazolidinediones.2
As a stand-alone therapy, semaglutide oral tablets resulted in a significant reduction in blood sugar compared with a placebo, as determined through HbA1c tests. After 26 weeks, 69% of those taking 7 mg once daily and 77% of those taking 14 mg once daily decreased their HbA1c to lower than 7%, compared with 31% of patients on the placebo.1
The prescribing information includes warnings for the potential increased risk of thyroid c-cell tumors, pancreatitis, diabetic retinopathy, hypoglycemia, acute kidney injury, and hypersensitivity reactions. The prescribing information also includes a boxed warning that semaglutide oral tablets are not recommended as the first choice of medicine for treating diabetes.1
Novo Nordisk’s semaglutide oral tablets will be available in the United States in the 4th quarter of 2019, according to the company.2
- FDA approves first oral GLP-1 treatment for type 2 diabetes. US Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-glp-1-treatment-type-2-diabetes. Published September 20, 2019. Accessed September 20, 2019.
- FDA approves Rybelsus (semaglutide), the first GLP-1 analog treatment available in a pill for adults with type 2 diabetes. Novo Nordisk. https://222.novonordisk-us.com/media/news-releases.html?122973. Published September 20, 2019. Accessed September 20, 2019.