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FDA Approves Ozempic for Add-On Treatment of Type 2 Diabetes

Novo Nordisk has just announced that the U.S. FDA (Food and Drug Administration) has approved their New Drug Application (NDA) for Ozempic. Ozempic (semaglutide) is a glucagon-like peptide (GLP-1) receptor agonist that is injected subcutaneously (under the skin) into the abdomen, thigh, or upper arm once a week. Ozempic is indicated for use in adults with type 2 diabetes, as an adjunct to diet and exercise, in order to help improve glycemic control. Ozempic comes in a pre-filled pen, and comes in either a 0.5 mg or 1.0 mg dosage. Ozempic is taken the same day each week, with or without food. Ozempic can also be taken at any time of the day.

How ozempic works, side effects and contraindications

Ozempic’s approval was based on results from a large Phase 3a clinical trial program, which involved over 8,000 adults with type 2 diabetes, including a two-year trial that investigated cardiovascular outcomes for adults with type 2 diabetes who were also at a high risk of experiencing cardiovascular events. The results of these trials indicated that taking Ozempic led to statistically significant and clinically meaningful reductions in A1c (a measure of blood glucose), when compared to exenatide extended-release, sitagliptin, and placebo. A secondary endpoint of these studies, experiencing significant reduction in body weight while taking Ozempic, was also met. The most common side-effects of Ozempic were diarrhea, abdominal pain, constipation, nausea, and vomiting. These adverse reactions were experienced by greater than or equal to 5% of individuals taking Ozempic.

Novo Nordisk is anticipating that Ozempic will be available in early 2018, and the pharmaceutical company has also announced their plans to help individuals access and pay for the treatment. Specifically, Novo Nordisk is planning to price the medication in a similar range as other GLP-1 receptor agonists on the market right now. Additionally, Novo Nordisk will be working with health insurance providers in attempts to find ways to reduce costs for consumers, as well as creating a savings card program to help reduce co-pays. Ozempic is currently being reviewed by the Japanese Pharmaceuticals and Medical Devices Agency, and the European Medicines Agency, for wide-spread use across the globe.

It may be possible to develop serious side-effects, such as thyroid tumors (including cancers), changes in vision, kidney problems, pancreatitis, and low blood sugar while taking Ozempic. It’s important to disclose your full medical history, as well as other medications you are taking, to your provider before starting Ozempic. Ozempic is not indicated for use by individuals with diabetic ketoacidosis or type 1 diabetes. Additionally, Ozempic should not be used as a substitute for insulin, nor should it be used as a first choice treatment for type 2 diabetes.

  1. Novo Nordisk Receives FDA Approval of Ozempic (semaglutide) Injection for the Treatment of Adults with Type 2 Diabetes. Novo Nordisk. Published December 2017. Accessed December 2017.