Rybelsus Approved as First-Line Treatment Option for Type 2 Diabetes

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Rybelsus Approved as First-Line Treatment Option for Type 2 Diabetes

The U.S. Food and Drug Administration (FDA) has approved Rybelsus (semaglutide) — the only GLP-1 agonist drug that is taken as a pill — as a first-line treatment option for type 2 diabetes, according to a press release from its manufacturer, Novo Nordisk.

GLP-1 receptor agonists are a group of type 2 diabetes drugs that lower blood glucose by doing the work of hormones that people with type 2 diabetes lack — leading to slower stomach emptying, less release of the hormone glucagon from the liver, and greater release of insulin from the pancreas. This group of drugs has been shown to have many potential benefits beyond their effect on blood glucose control. GLP-1 agonists may reduce the risk for glaucoma (an eye disease) in people who take them for diabetes, and have also been linked to a lower risk for asthma attacks, cardiovascular benefits, and a lower risk of dying in people with type 2 diabetes and kidney disease. Research suggests that given how effective they are, GLP-1 agonist are widely underused as a type 2 diabetes treatment — especially for people with a lower income or who belong to a racial or ethnic minority group.

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Rybelsus approved for daily use as a first-line type 2 treatment

According to the latest announcement, Rybelsus is now approved for daily use as a first-line treatment for type 2 diabetes in its currently available doses of 7- or 14-milligram tablets. Previously, the drug’s label stated that it should not be prescribed as an initial treatment for people who had not previously received a glucose-lowering drug for their type 2 diabetes. But the FDA removed this limitation after finding that there was not sufficient evidence to support it, given the drug’s potential benefits.

Rybelsus is unique among GLP-1 agonists in that it’s taken by mouth as a pill — all other GLP-1 agonists currently on the market are taken by injection weekly, daily, or twice daily. The active ingredient in Rybelsus is the same as in Ozempic (semaglutide), which is also manufactured and marketed by Novo Nordisk. Other GLP-1 agonists include Adlyxin (lixisenatide), Byetta (exenatide), Bydureon (exenatide extended release), Trulicity (dulaglutide), and Victoza (liraglutide).

Because of its unique formulation, Rybelsus must be taken on an empty stomach with a small amount of water. The pill must be swallowed whole, and you must refrain from eating, drinking, or taking other oral medicines for 30 minutes after taking Rybelsus. Currently, Rybelsus is approved only for adults with type 2 diabetes.

“In the U.S., hundreds of thousands of people with type 2 diabetes have been prescribed [Rybelsus] as part of their type 2 diabetes treatment regimen,” said Doug Langa, executive vice president for North America operations at Novo Nordisk, in the press release. “Rybelsus remains a pivotal part of our portfolio, making history as the first oral GLP-1 receptor agonist and helping to fuel our mission to improve the lives and health of people living with diabetes.”

According to the announcement from Novo Nordisk, the company continues to work with health insurance providers to ensure “broad insurance coverage” and affordable access to Rybelsus, with many people paying as little as $10 for a monthly prescription of the drug.

Want to learn more about type 2 diabetes? Read “Diabetes Testing: Type 2 Diabetes,” “Type 2 Diabetes and a Healthy Family Lifestyle,” and “Welcome to Diabetes.” 

Living with type 2 diabetes? Check out our free type 2 e-course!

Quinn Phillips

Quinn Phillips

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A freelance health writer and editor based in Wisconsin, Phillips has a degree from Harvard University. He is a former Editorial Assistant for Diabetes Self-Management and has years of experience covering diabetes and related health conditions. Phillips writes on a variety of topics, but is especially interested in the intersection of health and public policy.

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