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Home Industry News Novo Nordisk receives CHMP backing for EU approval of diabetes drug Ozempic

Novo Nordisk receives CHMP backing for EU approval of diabetes drug Ozempic

2nd January 2018

Novo Nordisk has announced that its new diabetes drug Ozempic has been recommended for European regulatory approval.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending marketing authorisation for Ozempic in the treatment of adults with type 2 diabetes.

Ozempic is the intended brand name for once-weekly semaglutide, with the treatment to be indicated as a monotherapy for patients for whom metformin no longer provides sufficient treatment, or is contraindicated.

Novo Nordisk's therapy has been shown to offer superior reductions in body weight compared to existing treatments, as well as delivering a statistically significant reduction in diabetic nephropathy relative to the current standard of care.  

Mads Krogsgaard Thomsen, executive vice-president and chief science officer of Novo Nordisk, said: "We are very excited about the positive opinion for Ozempic for treatment of people with type 2 diabetes in Europe, many of whom are still looking for new and more efficacious solutions to better manage their disease."

Novo Nordisk has pledged to conduct post-approval safety studies, including a long-term diabetic retinopathy outcome study, as part of the ratification process.

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