Novo Nordisk receives FDA approval of higher-dose Ozempic® 2 mg providing increased glycemic control for adults with type 2 diabetes

Ozempic^® demonstrated 2.1% blood sugar reduction and also weight loss in adults with type 2 diabetes with new 2 mg dose¹

PLAINSBORO, N.J., March 28, 2022 /PRNewswire/ -- Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved a 2 mg dose of Ozempic^® (semaglutide) injection, a once-weekly glucagon-like peptide-1 (GLP-1) analog indicated along with diet and exercise to improve blood sugar in adults with type 2 diabetes and to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes and known heart disease.² Ozempic^® is not a weight loss drug, but may help people lose some weight. Ozempic^® will be available in three therapeutic doses (0.5 mg, 1 mg, and 2 mg) to help people with type 2 diabetes reach their blood sugar (A1C) goal, now including those with a higher A1C who have been unable to meet their A1C target.

In the Ozempic^® SUSTAIN phase 3 clinical trial program, up to 73% of people with type 2 diabetes treated with Ozempic^® 1 mg lowered their blood sugar and reached the American Diabetes Association target of <7%.^3-5 Despite this, there are still people who are not at their blood sugar target.^1,4-10 Ozempic^® 2 mg helps those who need additional glycemic control and is an important option for patients and providers in the ongoing treatment of type 2 diabetes.

"Type 2 diabetes is a complex disease that can progress over time even if a person is managing it with medication, diet and exercise," said Dr Juan Pablo Frias, medical director of Velocity Clinical Research, Los Angeles and principal investigator of SUSTAIN FORTE, the phase 3 clinical trial that supports the Ozempic^® 2 mg approval. "With its proven safety and efficacy, Ozempic^® helps deliver on blood glucose control and offers major cardiovascular event risk reduction in adults with type 2 diabetes and known heart disease, plus it can help many patients lose some weight. With a 2 mg dose, we have an additional option so patients can stay on the same medication therapy even if their blood sugar needs shift."

In the SUSTAIN FORTE trial, people with an average starting A1C of 8.9% treated with Ozempic^® 2 mg achieved a statistically significant and superior reduction in blood sugar of 2.1% at week 40 compared to 1.9% with Ozempic^® 1 mg (P<0.01).¹ In the same study, people with an average starting weight of 219 lb treated with Ozempic^® 2 mg experienced a weight loss of 14.1 lb compared to a weight loss of 12.5 lb with Ozempic^® 1 mg; the difference was not statistically significant. For both doses of Ozempic^®, there were no new safety signals identified.¹ The most common adverse events were gastrointestinal.¹ Gastrointestinal adverse reactions occurred more frequently among patients receiving Ozempic^® 2 mg (34.0%) vs Ozempic^® 1 mg (30.8%).¹

"Ozempic^® is at the helm of helping Novo Nordisk drive change in diabetes care, with more than one million people with type 2 diabetes in the United States treated with Ozempic^®," said Doug Langa, executive vice president, North America operations and president of Novo Nordisk Inc. "With Ozempic^® now available in a variety of dosing strengths, we are optimistic we can help even more people living with type 2 diabetes who require more blood sugar control experience the benefits of Ozempic^®."   

Novo Nordisk expects to launch Ozempic^® 2 mg in the United States shortly. Ozempic^® 2 mg was approved by Swiss Medic in September 2021 followed by Health Canada and the European Medicines Agency in January 2022.

For health care professionals looking for more information about Ozempic^®, please visit OzempicPro.com. For consumers looking for more information about Ozempic^®, please visit Ozempic.com.

About the SUSTAIN FORTE clinical trial

The SUSTAIN FORTE trial was a part of the SUSTAIN clinical development program for once-weekly Ozempic^®. SUSTAIN FORTE studied the efficacy and safety of Ozempic^® 2 mg vs Ozempic^® 1 mg as add-on to metformin with or without a sulfonylurea in people with type 2 diabetes in need of treatment intensification.¹ The trial achieved its primary endpoint by demonstrating a statistically significant and superior reduction in A1C at week 40 with Ozempic^® 2 mg compared to Ozempic^® 1 mg.¹

For more information about the SUSTAIN FORTE trial, please read the results here.  

What is Ozempic®?

Ozempic^® (semaglutide) injection 0.5 mg, 1 mg, or 2 mg is an injectable prescription medicine used:

• along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes mellitus.
  to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes mellitus with known heart disease.

It is not known if Ozempic^® can be used in people who have had pancreatitis.
Ozempic^® is not for use in people with type 1 diabetes.
It is not known if Ozempic^® is safe and effective for use in children under 18 years of age.

Important Safety InformationDo not share your Ozempic® pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.What is the most important information I should know about Ozempic®?Ozempic® may cause serious side effects, including:

• Possible thyroid tumors, including cancer. Tell your health care 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, Ozempic^® and medicines that work like Ozempic^® caused thyroid tumors, including thyroid cancer. It is not known if Ozempic^® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
• Do not use Ozempic^® 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).

Do not use Ozempic® if:

• you or any of your family have ever had MTC or if you have MEN 2.
• you are allergic to semaglutide or any of the ingredients in Ozempic^®. See symptoms of serious allergic reaction in "What are the possible side effects of Ozempic^®?"

Before using Ozempic®, tell your health care 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 diabetic retinopathy.
• are pregnant or breastfeeding or plan to become pregnant or breastfeed. It is not known if Ozempic^® will harm your unborn baby or passes into your breast milk. You should stop using Ozempic^® 2 months before you plan to become pregnant.

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and other medicines to treat diabetes, including insulin or sulfonylureas.What are the possible side effects of Ozempic®?Ozempic® may cause serious side effects, including:

• inflammation of your pancreas (pancreatitis). Stop using Ozempic^® and call your health care 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 health care provider if you have changes in vision during treatment with Ozempic^®.
• low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Ozempic^® 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 Ozempic^® 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 Ozempic^®. Tell your healthcare provider right away if you get symptoms which may include: pain in your upper stomach (abdomen), fever, yellowing of the skin or eyes (jaundice) or clay-colored stools.

The most common side effects of Ozempic® may include nausea, vomiting, diarrhea, stomach (abdominal) pain, and constipation.Please see Medication Guide and Prescribing Information, including Boxed Warning, for Ozempic®at https://www.novo-pi.com/ozempic.pdf.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 more than 95 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 US 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.us, Facebook , Instagram and Twitter.

References

Frias JP, Auerbach P, Bajaj HS, et al. Efficacy and safety of once-weekly semaglutide 2.0 mg versus 1.0 mg in patients with type 2 diabetes (SUSTAIN FORTE): a double-blind, randomised, phase 3B trial. Lancet Diabetes Endocrinol. 2021;9:563-574.

FDA. Ozempic^® (semaglutide) injection US Prescribing Information. Accessed March 2022. https://www.novo-pi.com/ozempic.pdf.

American Diabetes Association. Standards of medical care in diabetes - 2022. Diabetes Care. 2022;45(suppl 1):S1-258

Sorli C, Harashima SI, Tsoukas GM, et al. Efficacy and safety of once-weekly semaglutide monotherapy versus placebo in patients with type 2 diabetes (SUSTAIN 1): a double-blind, randomised, placebo-controlled, parallel-group, multinational, multicentre phase 3a trial. Lancet Diabetes Endocrinol. 2017;5:251-260.

Pratley RE, Aroda VR, Lingvay I, et al. Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial. Lancet Diabetes Endocrinol. 2018;6:275-286.

Ahren B, Masmiquel L, Kumar H, et al. Efficacy and safety of once-weekly semaglutide versus once-daily sitagliptin as an add-on to metformin, thiazolidinediones, or both, in patients with type 2 diabetes (SUSTAIN 2): a 56-week, double-blind, phase 3a, randomised trial. Lancet Diabetes Endocrinol. 2017;5:341-354.

Ahmann AJ, Capehorn M, Charpentier G, et al. Efficacy and safety of once-weekly semaglutide versus exenatide ER in subjects with type 2 diabetes (SUSTAIN 3): A 56-Week, Open-Label, Randomized Clinical Trial. Diabetes Care. 2018;41:258-266.

Aroda VR, Bain SC, Cariou B, et al. Efficacy and safety of once-weekly semaglutide versus once-daily insulin glargine as add-on to metformin (with or without sulfonylureas) in insulin-naive patients with type 2 diabetes (SUSTAIN 4): a randomised, open-label, parallel-group, multicentre, multinational, phase 3a trial. Lancet Diabetes Endocrinol. 2017;5:355-366.

Rodbard HW, Lingvay I, Reed J, et al. Semaglutide added to basal insulin in type 2 diabetes (SUSTAIN 5): A Randomized, Controlled Trial. J Clin Endocrinol Metab. 2018;103:2291-2301.

Gaede P, Catarig A-M, Dungan KM, Hindsberger C, Ølligaard J, Bain SC. 660-P: Greater proportions of subjects achieved composite endpoints with once-weekly semaglutide vs. comparators in SUSTAIN Trials. Diabetes. 2021;70(Supplement_1). doi:10.2337/db21-660-p

Ozempic^® is a registered trademark of Novo Nordisk A/S.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
© 2022 Novo Nordisk  All rights reserved.  US21OZM01000  March 2022

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SOURCE Novo Nordisk