Ozempic (semaglutide) has been approved by the US Food and Drug Administration to treat type 2 diabetes alongside diet and exercise.
Ozempic, a once-weekly injection of glucagon-like peptide-1 (GPL-1), was approved following data from studies which revealed the drug improved HbA1c levels and also enables weight loss.
The Novo Nordisk drug will now become available in the US in 0.5mg and 1.0mg doses, to be administered once a week using a dedicated 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 following an advisory panel endorsement in October, where clinical trials involving more than 8,000 adults with type 2 diabetes were reviewed.
In five SUSTAIN trials, Ozempic lowered HbA1c by 17 to 20 mmol/mol (1.5 to 1.8%), and outperformed another GLP-1 agonist, Bydureon (exenatide), in one of the trials.
Ozempic was also associated with weight loss of between 4.5-6.4kg, and studies have demonstrated Ozempic can reduce the risk of heart disease.
Mads Krogsgaard Thomsen, executive vice president and chief science officer at Novo Nordisk, said:
“We are very excited about the first approval of Ozempic and look forward to making this important innovation available to people in the US with type 2 diabetes in the beginning of 2018.”
Side effects of the drug included mild to moderate nausea, vomiting and constipation, but these weakened over time.
Earlier this year an oral version of semaglutide was shown to have similar benefits to injectable semaglutide, but further research needs to be conducted before this is sent for approval.
Diabetes.co.uk editor’s note: People with type 2 diabetes who have joined our Low Carb Program have come off medicationaltogether by making lifestyle changes, such as eating a healthy diet, and normalising their blood sugar levels. The program can also help with weight loss and improving overall health.
Originally published by Jack Woodfield at Diabetes.co.uk
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