The US Food and Drug Administration (FDA) has been approved Ozempic (semaglutide) to treat type 2 diabetes alongside diet and exercise. Ozempic, a once-weekly injection of glucagon-like peptide-1 (GPL-1), was approved following information from studies which revealed the medication improved HbA1c levels and furthermore weight loss.
The Novo Nordisk medication will now end up become available in the US in 0.5mg and 1.0mg doses, to be administered once seven days using a using prefilled pen device. Ozempic is also under review for approval by the European Medicines Agency following submission by Novo Nordisk in 2016.
The FDA’s decision was made after an advisory panel endorsement in October, where clinical trials involving more than 8,000 grown-ups with type 2 diabetes were reviewed. In five SUSTAIN trials, Ozempic lowered HbA1c by 17 down to 20 mmol/mol (1.5 to 1.8%) and outperformed another GLP-1 agonist, Bydureon (exenatide), in one of the trials.
Ozempic was additionally connected with the weight reduction of between 4.5-6.4kg and examines have shown Ozempic can decrease the risk of heart disease.
Mads Krogsgaard Thomsen, executive VP and chief science officer at Novo Nordisk, said: “We are very excited about the first approval of Ozempic and look forward to making this vital innovation available to individuals in the US with type 2 diabetes in the start of 2018.”
Side impacts of the medication included mild to moderate nausea, vomiting, and constipation, however, these weakened after some time.
Prior this year an oral version of semaglutide was appeared to have comparable advantages to injectable semaglutide, however additionally research about should be conducted before this is sent for approval.
About Ozempic (semaglutide):
Semaglutide causes thyroid C-cell tumors. It is unknown whether OZEMPIC causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in people as the human relevance of semaglutide- induced rodent thyroid C-cell tumors have not been determined.
OZEMPIC is contraindicated in patients with an individual or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2. Counsel patients with respect to the potential risk of MTC and symptoms of thyroid tumors.