Novo’s Ozempic secures European approval in type 2 diabetes

pharmafile | February 12, 2018 | News story | Sales and Marketing EC, EMA, Europe, Novo Nordisk, diabetes, pharma 

Novo Nordisk has revealed that its drug Ozempic (semaglutide) has received approval from the European Commission (EC) as a monotherapy for the treatment of type 2 diabetes in patients for whom metformin is inappropriate.

The EC’s decision was based on data which demonstrates “the superior and sustained reductions in HbA1c and body weight” associated with the use of Ozempic compared to similar treatments, in addition to “cardiovascular benefits and the statistically significant reduction in diabetic nephropathy”.

The approval of the once-weekly analogue of human glucagon-like peptide-1 (GLP-1) covers its use in a multi-dose pen form, though Novo Nordisk noted its intention to submit a variation application to the EMA to secure approval of an updated pen offering which “will help facilitate reimbursement for patients with type 2 diabetes using Ozempic”.

“We are very excited about the approval of Ozempic in the EU, as we believe it has the potential to set a new standard for the treatment of type 2 diabetes,” said Mads Krogsgaard Thomsen, Executive Vice President and Chief Science Officer. “Type 2 diabetes is a complex disease and the strong clinical profile of Ozempic provides a much needed treatment option for people looking for efficacious solutions to manage their disease.”

The therapy secured US approval from the FDA in December last year, as well as approval in Canada last month.

Matt Fellows

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