On December 5th 2017, semaglutide (Ozempic®), developed by Novo Nordisk, received its first global approval in the US.[1] Nine days later the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion in the EU.[2] This was followed swiftly by Health Canada’s approval in January 2018.[3] [4] In all cases, semaglutide was approved for use in adults with type 2 diabetes mellitus, as an adjunct to diet and exercise to improve glycaemic control. The drug is dispensed as prefilled pens for subcutaneous injection once weekly. Semaglutide is a glucagon-like peptide (GLP-1) receptor agonist that stimulates insulin and suppresses glucagon secretion in a glucose-dependent manner.[3] It is administered on the same day each week, at any time and without regard for food intake.[1]

Helena Rodbard, MD, FACP, MACE, medical director, Endocrine and Metabolic Consultants, Rockville, MD, described type 2 diabetes as, “a serious condition that affects more than 28 million people in the U.S.” She went on to explain that, “despite advancements in treatment, some people with type 2 diabetes do not achieve their A1c goals.” However, she stated that the approval of semaglutide “offers healthcare professionals an important new treatment option to help adults with type 2 diabetes meet their A1c goals.” [1]

Approval of semaglutide was based on the results from the SUSTAIN clinical program that comprised ten phase III trials, and included more than 8000 patients globally. [5] Data from these trials indicated (as secondary endpoint) that semaglutide had a positive impact on weight loss; bodyweight is considered a major contributing factor to the development of type-2 diabetes mellitus.

“The availability of a once-weekly injectable associated with effective glucose lowering and weight loss is a welcome addition to our treatment options,” explained Dr. Lawrence Leiter, Professor of Medicine at the University of Toronto. This is because, “many of our patients with type 2 diabetes are overweight and have elevated blood sugar levels despite lifestyle changes and current therapies.” [3]

Furthermore, Dr. Jan Hux, President and Chief Science Officer, Diabetes Canada, commented that, “it is critically important that both population health and clinical approaches are applied to help prevent the onset and consequences of diabetes, including solutions designed to manage weight.” [3]

Prescribing information for semaglutide carries black box warnings with regard to the risk of developing Thyroid C-cell Tumours based on observations in rodents. The agent is contraindicated in patient with a personal or family history of Medullary Thyroid Carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). [4] [6]

Semaglutide is also under regulatory review with the Japanese Pharmaceuticals and Medical Devices Agency for the same indication as previously described. [1]

 For further information related to the first global approval of semaglutide, please visit Adis’ journal Drugs[7], where it has been reviewed in detail based on the development milestones tracked in AdisInsight[5].

 

Image credit: Jess Watters

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