Novo Nordisk announces FDA approval of label update for Rybelsus® (semaglutide) allowing use as a first-line option for adults with type 2 diabetes

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Jan 12, 2023, 20:28 ET

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 A1C^1,2
Since its approval, Rybelsus^® has been prescribed to hundreds of thousands of patients to help improve glycemic control along with diet and exercise³

PLAINSBORO, 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.

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

Important Safety Information

What is the most important information I should know about RYBELSUS^®?

RYBELSUS^® may cause serious side effects, including:

Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, RYBELSUS^® and medicines that work like RYBELSUS^® caused thyroid tumors, including thyroid cancer. It is not known if RYBELSUS^® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people

Do not use RYBELSUS^® if:

you or any of your family have ever had MTC, or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
you have had a serious allergic reaction to semaglutide or any of the ingredients in RYBELSUS^®. See symptoms of serious allergic reaction in "What are the possible side effects of RYBELSUS^®?"

Before using RYBELSUS^®, tell your healthcare provider if you have any other medical conditions, including if you:

have or have had problems with your pancreas or kidneys
have a history of vision problems related to your diabetes
are pregnant or plan to become pregnant. It is not known if RYBELSUS^® will harm your unborn baby. You should stop using RYBELSUS^® 2 months before you plan to become pregnant. Talk to your healthcare provider about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant
are breastfeeding or plan to breastfeed. Breastfeeding is not recommended during treatment with RYBELSUS^®

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^®?

Take RYBELSUS^® exactly as your healthcare provider tells you to
Take RYBELSUS^® by mouth on an empty stomach when you first wake up with a sip of plain water (no more than 4 ounces)
Do not split, crush, or chew. Swallow RYBELSUS^® whole
After 30 minutes, you can eat, drink, or take other oral medicines
If you miss a dose of RYBELSUS^®, skip the missed dose and go back to your regular schedule

What are the possible side effects of RYBELSUS^®?

RYBELSUS^® may cause serious side effects, including:

inflammation of your pancreas (pancreatitis). Stop using RYBELSUS^® and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back
changes in vision. Tell your healthcare provider if you have changes in vision during treatment with RYBELSUS^®
low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use RYBELSUS^® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include: dizziness or lightheadedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, and feeling jittery
kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration
serious allergic reactions. Stop using RYBELSUS^® and get medical help right away, if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat
gallbladder problems. Gallbladder problems have happened in some people who take RYBELSUS^®. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include: pain in your upper stomach (abdomen), yellowing of skin or eyes (jaundice), fever, and clay-colored stools

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.