The U.S. Food and Drug Administration has approved\u00a0Novo Nordisk’s\u00a0New Drug Application for\u00a0OZEMPIC\u00a0(semaglutide) injection 0.5 mg or 1 mg, a once-weekly glucagon-like peptide (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.\u00a0OZEMPIC\u00a0is administered once weekly, on the same day each week, and can be taken any time of the day, with or without meals.<\/p>\n
The approval of OZEMPIC\u00a0is based on the results from a Phase 3a clinical trial program. In people with type 2 diabetes, OZEMPIC\u00a0showed clinically meaningful and statistically significant reductions in A1c\u00a0compared with placebo, sitagliptin and exenatide extended-release.\u00a0As a secondary endpoint in the trials, treatment with OZEMPIC\u00a0resulted in reductions in body weight.\u00a0The most common adverse reactions reported in 5% of patients treated with OZEMPIC\u00a0are: nausea, vomiting, diarrhea, abdominal pain and constipation.<\/p>\n
\u201cThe OZEMPIC\u00a0approval builds on Novo Nordisk\u2019s commitment to offering healthcare professionals a range of treatments that effectively addresses the complex needs of diabetes management and fits their patients\u2019 lifestyles,\u201d said Todd Hobbs, vice president and U.S. chief medical officer of Novo Nordisk. \u201cWe 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\u00a0to the type 2 diabetes community.\u201d<\/p>\n
OZEMPIC\u00a0is approved for use in two therapeutic doses, 0.5 mg and 1 mg, and will be launched in the OZEMPIC\u00a0pre-filled pen.<\/p>\n
The global Phase 3a clinical trial program for OZEMPIC\u00a0comprised eight clinical trials involving more than 8,000 adults with type 2 diabetes, including a two-year cardiovascular outcomes trial that evaluated safety in adults with type 2 diabetes at high risk of cardiovascular events.<\/p>\n
\u201cType 2 diabetes is a serious condition that affects more than 28 million people in the U.S., and despite advancements in treatment, some people with type 2 diabetes do not achieve their A1c goals,\u201d said Helena Rodbard, MD, FACP, MACE, medical director, Endocrine and Metabolic Consultants, Rockville, MD, and past president of the American Association of Clinical Endocrinologists. \u201cThe approval of semaglutide offers healthcare professionals an important new treatment option to help adults with type 2 diabetes meet their A1c goals.\u201d<\/p>\n
Novo Nordisk expects to launch OZEMPIC\u00a0in the U.S. in Q1 2018, with a goal of ensuring broad insurance coverage and patient access to the product. OZEMPIC\u00a0will be priced at parity to current market-leading weekly GLP-1 receptor agonists and will be offered with a savings card program to reduce co-pays for eligible commercially-insured patients.\u00a0Additionally, as part of the\u00a0access strategy, Novo Nordisk is working with appropriate health insurance providers to establish innovative contracting solutions.<\/p>\n
Semaglutide is currently under review by the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency.<\/p>\n","protected":false},"excerpt":{"rendered":"
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