Novo Nordisk announces FDA approval of label update for Rybelsus® (semaglutide) allowing use as a first-line option for adults with type 2 diabetes
- Category: Proteins and Peptides
- Published on Friday, 13 January 2023 11:00
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- People living with type 2 diabetes can now take Rybelsus®, the first and only oral glucagon-like peptide-1 (GLP-1) analog, along with diet and exercise, as initial therapy to help lower their A1C1,2
- Since its approval, Rybelsus® has been prescribed to hundreds of thousands of patients to help improve glycemic control along with diet and exercise3
PLAINSBORO, NJ, USA I January 12, 2023 I The U.S. 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.1,2
"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.1,2 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.4
"In the U.S., 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.
What is RYBELSUS®?
RYBELSUS® (semaglutide) tablets 7 mg or 14 mg is a prescription medicine used along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes.
- It is not known if RYBELSUS® can be used in people who have had pancreatitis
- RYBELSUS® is not for use in people with type 1 diabetes
- It is not known if RYBELSUS® is safe and effective for use in children under 18 years of age
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.1,2
About Novo Nordisk
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. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity and rare blood and endocrine disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term and do business in a financially, socially, and environmentally responsible way. With U.S. headquarters in New Jersey and production and research facilities in seven states, Novo Nordisk employs nearly 6,000 people throughout the country. For more information, visit novonordisk.com, Facebook, Instagram, and Twitter.
1. Rybelsus® [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2023.
2. Rodbard HW, Dougherty T, Taddei-Allen P. Efficacy of oral semaglutide: overview of the PIONEER clinical trial program and implications for managed care. Am J Manag Care. 2020;26(suppl 16):S335-S343.
3. IQVIA LAAD AOM and Diabetes Rx. October, 2022.
4. Buckley ST, Baekdal TA, Vegge A, et al. Transcellular stomach absorption of a derivatized glucagon-like peptide-1 receptor agonist. Sci Transl Med. 2018;10(467):eaar7047.
SOURCE: Novo Nordisk