FDA Approves Rybelsus, First Oral GLP-1 Medicine

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FDA approval stamp -- FDA Approves Rybelsus, First Oral GLP-1 Medicine

The U.S. Food and Drug Administration (FDA) has approved the first oral GLP-1 medicine for blood sugar management in adults with type 2 diabetes. Manufactured by Novo Nordisk, Rybelsus (semaglutide) oral tablets are the first drug in their class that do not need to be injected.

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A member of the class of medicines known as GLP-1 inhibitors, it works by increasing feelings of fullness, slowing stomach emptying, increasing the release of insulin, and decreasing the release of glucagon (a hormone that raises blood glucose).

Rybelsus is approved for once-daily use in 7-milligram or 14-milligram doses and is expected to be available in the United States in the fourth quarter of 2019. According to the manufacturer, “A savings card program will be available at the time of launch for eligible commercially-insured patients to keep out of pocket costs down to as little as $10 a month.”

“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,” noted 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.”

To learn more about Rybelsus, read the press releases from the FDA or Novo Nordisk.

Want to learn more about the GLP-1 inhibitor class of medicines? Read “Non-Insulin Injectable Diabetes Medicines.”

Diane Fennell

Diane Fennell

Editorial Director of the Wellness Division, Fennell has 16 years’ experience specializing in diabetes and related health conditions. Based in New York City, she has a degree from Columbia University.

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