Authorization was granted in February 2018 for the European Union, in March 2018 in Japan, on 4 January 2018 in Canada, and in August 2019 in Australia.In November 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion on Wegovy, the formulation intended for the treatment of people with obesity or who are overweight in the presence of other related conditions, recommending the granting of a marketing authorization. The applicant for this medicinal product is Novo Nordisk A/S. Wegovy was approved for medical use in the European Union in January 2022. 2022 shortages
As a result of an increase in prescriptions for weight loss in non-diabetic patients, a shortage of Semaglutide/Ozempic was reported in Australia in 2022. This shortage resulted in many people with type 2 diabetes being unable to access the drug. In May 2022, the Australian Therapeutic Goods Administration, along with Novo Nordisk, sent out guidelines to all health professionals, reminding them that people with type 2 diabetes need to be prioritised in terms of supply. An update to the guidelines was released in August 2022.Shortages were also reported contemporaneously in the United States In the same month, rival Eli Lilly stated in its quarterly investors call that it was working "around the clock" to ensure adequate supply of its rival GLP-1 agonist tirzepatide (Mounjaro).
A 2022 review of anti-obesity treatments found that semaglutide as well as tirzepatide (which has an overlapping mechanism of action) were more promising than previous anti-obesity drugs, although less effective than bariatric surgery. Adverse effects
Side effects include nausea, vomiting, diarrhea, abdominal pain, and constipation. In people with heart problems, it can cause damage to the retina of the eye (retinopathy). Other, less common side effects include kidney problems, allergic reactions, low blood sugar, and pancreatitis. Contraindications
Due to data from rodents studies of GLP1 mediated thyroid C-cell hyperplasia, their use is contraindicated in patients with a personal or family history of medullary thyroid carcinoma and in patients with multiple endocrine neoplasia syndrome type 2. Mechanism of action
Semaglutide is a glucagon-like peptide-1 receptor agonist. By mimicking the action of the incretin GLP-1, it increases the production of insulin, a hormone that lowers the blood sugar level. It appears to enhance growth of pancreatic beta cells, which are responsible for insulin production and release. It also inhibits the production of glucagon, which is a hormone that increases glycogenolysis (release of stored carbohydrate from the liver) and gluconeogenesis (synthesis of new glucose). It reduces food intake by lowering appetite and slowing down digestion in the stomach, helping to reduce body fat. Its half-life in the blood is about seven days (165–184 hours). Structure
Semaglutide is chemically similar to human GLP-1, with 94% similarity. The only differences are two amino-acid substitutions at positions 8 and 34, where alanine and lysine are replaced by 2-aminoisobutyric acid and arginine, respectively.