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Novo Nordisk Receives FDA Approval of Higher-Dose Ozempic 2 mg Providing Increased Glycemic Control for Adults with Type 2 Diabetes

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

What is Ozempic®?

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

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 Information
Do 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:
Do not use Ozempic® if:
Before using Ozempic®, tell your health care provider if you have any other medical conditions, including if you:
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:
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 http://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
  1. 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.
  2. FDA. Ozempic® (semaglutide) injection US Prescribing Information. Accessed March 2022. https://www.novo-pi.com/ozempic.pdf.
  3. American Diabetes Association. Standards of medical care in diabetes - 2022. Diabetes Care. 2022;45(suppl 1):S1-258
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. 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

SOURCE Novo Nordisk

Posted: March 2022

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