US FDA approves label update for Novo Nordisk Rybelsus allowing use as a first-line option for adults with type 2 diabetes

The US Food and Drug Administration (FDA) has approved a label update for Rybelsus (semaglutide) tablets 7 mg or 14 mg, allowing use as a first-line treatment option for adults with type 2 diabetes who have not previously taken a diabetes treatment. This update removes a previous limitation of use that stated the medication should not be used as the initial therapy for treating patients with type 2 diabetes. Initially approved by the FDA in 2019, Rybelsus is the first and only GLP-1 analog in pill form and is indicated, along with diet and exercise, to improve glycemic control for adults with type 2 diabetes. "The removal of the limitation of use is an important step forward for people living with type 2 diabetes and provides the option for Rybelsus to be taken earlier," said Dr. Aaron King, Family Medicine and Diabetes Specialist. "By taking Rybelsus first, people with type 2 diabetes, in conjunction with their care teams, are now able to utilize this medicine early in their diabetes treatment journeys." Rybelsus works differently than other diabetes pills to lower blood sugar in three ways: by increasing the release of insulin from the pancreas when blood sugar is high, decreasing the release of sugar from the liver, and slowing the process of food leaving the stomach after eating. Rybelsus comprises a unique co-formulation of semaglutide and an absorption enhancer called SNAC (sodium N-(8-[2-hydroxybenzoyl] amino) caprylate), which facilitates absorption of semaglutide in the stomach, making it possible to provide semaglutide as a pill. "In the US, hundreds of thousands of people with type 2 diabetes have been prescribed this medicine as part of their type 2 diabetes treatment regimen to help lower their A1C," said Doug Langa, executive vice president, North America operations and president of Novo Nordisk. "As Novo Nordisk marks 100 years of commitment and innovation in diabetes care, 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." Novo Nordisk works with health insurance providers to ensure broad insurance coverage and patient access to Rybelsus. Eligible, commercially insured patients may pay as little as $10 for a one- to three-month prescription of this medicine. Rybelsus (semaglutide) tablets 7 mg or 14 mg is an analog of the naturally occurring hormone glucagon-like peptide-1 (GLP-1). Rybelsus is the first and only GLP-1 receptor agonist (RA) in a pill. It is taken once daily and is approved for use in two therapeutic doses: 7 mg and 14 mg. Novo Nordisk is a leading global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for nearly 100 years.

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