Novo Nordisk's once-weekly GLP-1 agonist Ozempic gains EU approval

Novo Nordisk announced Friday the European approval of the once-weekly GLP-1 agonist Ozempic (semaglutide) for the treatment of adults with type 2 diabetes. The drug is indicated as monotherapy when metformin is considered inappropriate due to intolerance or is contraindicated, and as an addition to other medicinal products for the treatment of diabetes.

Ozempic gained FDA approval in December last year, with the drug gaining clearance last month in Canada. "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," commented Mads Krogsgaard Thomsen, chief science officer at Novo Nordisk.

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The EU approval follows a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use in December last year and is based on data from the SUSTAIN programme, which comprised eight Phase III studies. Novo Nordisk noted that Ozempic's label reflects the "superior and sustained" reductions in HbA1c and body weight achieved relative to comparator treatments, cardiovascular benefits and the significant reduction in diabetic nephropathy relative to standard of care.

According to the company, Ozempic has been approved in the EU for use in a multi-dose Ozempic pen. However, Novo Nordisk noted that it plans to submit an application to the EMA seeking approval of an updated pen, which will "help facilitate reimbursement" for patients with type 2 diabetes using Ozempic. The drugmaker added that Ozempic is expected to be launched in the first EU countries in the second half of 2018.

For related analysis, see Spotlight On: Novo Nordisk's Ozempic (semaglutide) – SWOT analysis.

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