Novo Nordisk announces FDA approval of label update for Rybelsus … – BioSpace


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Published: Jan 13, 2023
PLAINSBORO, N.J., Jan. 12, 2023 /PRNewswire/ — 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.
For more information about Rybelsus®, visit Rybelsus.com. For health care professionals, please visit RybelsusPro.com.
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.
Important Safety Information
What is the most important information I should know about RYBELSUS®?
RYBELSUS® may cause serious side effects, including:
Do not use RYBELSUS® if:
Before using RYBELSUS®, tell your healthcare provider if you have any other medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RYBELSUS® may affect the way some medicines work and some medicines may affect the way RYBELSUS® works.
How should I take RYBELSUS®?
What are the possible side effects of RYBELSUS®?
RYBELSUS® may cause serious side effects, including:
The most common side effects of RYBELSUS® may include nausea, stomach (abdominal) pain, diarrhea, decreased appetite, vomiting, and constipation. Nausea, vomiting, and diarrhea are most common when you first start RYBELSUS®.
Please click here for Prescribing Information and Medication Guide for RYBELSUS®.
About Rybelsus®
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.

References
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.
Rybelsus® is a registered trademark of Novo Nordisk A/S.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
© 2023 Novo Nordisk All rights reserved. US22RYB00980 January 2023
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SOURCE Novo Nordisk
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