FDA Approves Novo Nordisk's Rybelsus Diabetes Tablets

By Chris Wack

The U.S. Food and Drug Administration said Friday it approved Novo Nordisk's (NVO) Rybelsus semaglutide oral tablets to improve control of blood sugar in adult patients with type 2 diabetes, along with diet and exercise.

The FDA said Rybelsus is the first glucagon-like peptide, or GLP-1, receptor protein treatment approved for use in the U.S. that doesn't need to be injected. GLP-1 drugs are non-insulin treatments for people with type 2 diabetes.

The FDA said like GLP-1, Rybelsus slows digestion, prevents the liver from making too much sugar, and helps the pancreas produce more insulin when needed.

Novo Nordisk said it is working with health insurance providers with a goal of ensuring broad insurance coverage and patient access to the product. 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.

The FDA is still reviewing Novo Nordisk's new drug application for Rybelsus, seeking an additional indication to reduce the risk of major adverse cardiovascular events such as heart attack, stroke, or cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. A decision is expected in the first quarter of 2020.

Novo Nordisk said Rybelsus is currently under review by several regulatory agencies around the world, including the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency.

Write to Chris Wack at [e-mail]

(END) Dow Jones Newswires

September 20, 2019 11:15 ET (15:15 GMT)

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