Novo Nordisk Bags FDA Approval for New Diabetes Treatment

Ozempic will compete with Trulicity (Eli Lilly & Co.) and Bydureo (AstraZeneca).

Type 2 diabetes affects nearly 30 million people in the United States, most of whom are adults. The disease occurs when the body can no longer produce sufficient quantities of insulin or effectively use the insulin that it does produce. People with this disease are two to four times more likely to have cardiovascular disease than those without diabetes. Fortunately, diabetes can be managed with lifestyle changes (balanced diet, exercise and medication).

"Despite advancements in treatment, some people with type 2 diabetes do not achieve their A1c goals," said Helena Rodbard, MD, FACP, MACE, medical director, Endocrine and Metabolic Consultants, Rockville, MD, and past president of the American Association of Clinical Endocrinologists.

Novo Nordisk, with the approval of its latest diabetes drug OZEMPIC® (semaglutide) injection 0.5 mg or 1 mg by the U.S. Food and Drug Administration (FDA), will be able to offer another option for adults with type 2 diabetes that are struggling to meet their A1c goals. The drug is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

Semaglutide is an analog of native human glucagon-like peptide-1 (GLP-1) with high albumin binding, which results in a long half-life of approximately one week. As a result, it only needs to be administered once per week to effectively stimulate insulin production and lower glucagon secretion in a glucose-dependent manner. In a Phase 3a study comprising eight clinical trials and over 8,000 adults with type 2 diabetes, patients taking OZEMPIC® showed clinically meaningful and statistically significant reductions in A1c compared with placebo, sitagliptin and exenatide extended-release.

The main competitor for OZEMPIC® will be Eli Lilly’s Trulicity (dulaglutide), which is also a glucagon-like peptide 1 receptor agonist and a once-weekly treatment. In addition to lowering glucagon secretion, OZEMPIC® demonstrated heart and weight-loss benefits compared to its rival products. Analysts estimate it could achieve annual sales of $3.17 billion by 2023. Novo Nordisk indicated that it would be pricing OZEMPIC® at parity to current market-leading weekly GLP-1 receptor agonists. The drug will be offered as the OZEMPIC® pre-filled pen.

"The OZEMPIC® approval builds on Novo Nordisk's commitment to offering healthcare professionals a range of treatments that effectively addresses the complex needs of diabetes management and fits their patients' lifestyles," said Todd Hobbs, Vice President and U.S. Chief Medical Officer of Novo Nordisk. "We are grateful to the many adults with type 2 diabetes who participated in the studies, as well as the clinical trial investigators. Thanks to their collective contributions, Novo Nordisk is able to bring once-weekly OZEMPIC® to the type 2 diabetes community."

Novo Nordisk has also submitted new drug applications for semaglutide to the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency. 


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