Denmark-based Novo Nordisk yesterday announced that the European Commission has approved Ozempic (semaglutide) for the treatment of type-2 diabetes as a once-weekly treatment in a Multi-Dose Pen. Novo Nordisk expects to launch Ozempic in Europe in H2 2018. Ozempic has already been approved in Canada in January 2018 and in the US in December 2017. The approval reflects the positive results from a Phase IIIa clinical trial conducted for 40 weeks on 1,200 patients, which has shown that Ozempic lowers glucose level with better results than Eli Lilly’s dulaglutide.
The active substance in Ozempic, semaglutide, is a ‘GLP-1 receptor agonist’. It acts in the same way as GLP-1 (a hormone produced in the gut) by increasing the amount of insulin that the pancreas releases in response to food. This helps with the control of blood glucose levels.
Ozempic was shown to be effective at controlling blood glucose levels. Treatment with Ozempic also led to weight loss, which is considered beneficial in patients with diabetes. Ozempic was also shown to be effective at reducing the occurrence of serious health complications associated with diabetes such as heart attack and stroke.
Regarding safety, this was considered in line with that of other medicines of the same class. Side effects affecting the digestive system are considered to be manageable. Worsening of diabetic retinopathy has also been observed and will be further investigated.
The European Medicines Agency concluded that the benefits of Ozempic seen in studies outweighed its risk and recommended it be approved for use in the EU.
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