Novo Nordisk Receives Fda Approval of Higher-dose Ozempic® 2 Mg Providing Increased Glycemic Control for Adults With Type 2 Diabetes

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.