Rybelsus Approved As Novel Treatment for Diabetes

September 20, 2019 – The U.S. FDA has approved Rybelsus® (semaglutide) oral tablets, manufactured by Novo Nordisk, as an adjunct to diet and exercise to improve glycemic control in adults who have type 2 diabetes mellitus. Rybelsus is the first FDA-approved glucagon-like peptide-1 (GLP-1) receptor agonist with an oral route of administration.

Approximately 28 million individuals in the United States have type 2 diabetes. It is the most common form of diabetes in the United States, and treatments include lifestyle changes such as dietary adjustments and physical activity to help control blood sugar levels. Medications can further assist in achieving appropriate blood sugar levels.

Prior to the FDA’s approval of Rybelsus, GLP-1 receptor agonists were available only in injectable forms. Because patients are likely to be more comfortable with oral tablets, Rybelsus could remove barriers to the use of GLP-1 receptor agonists in diabetes treatment. Rybelsus reduced A1C, a common measure of glycemic control, in clinical trials. Patients on the medication also experienced reductions in body weight.

Recommended dosing is 3mg once daily for 30 days, followed by an increase to 7mg once daily. If additional glycemic control is still needed after 30 days on the 7mg dose, patients can take 14mg once daily. Each dose should be taken at least 30 minutes before the first food, beverage, or other oral medication of the day with no more than 4oz of plain water. The drug carries a black box warning that the active ingredient (semaglutide) has caused thyroid C-cell tumors in rodents. At this juncture, it is unknown whether Rybelsus may cause these tumors in humans. However, it should not be used in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Novo Nordisk plans to launch Rybelsus before the end of 2019. It will be available at a list price of $772 per 30 tablets – just two dollars less the cost for a one-month supply of Ozempic®, Novo Nordisk’s injectable form of semaglutide.