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Novo submits Degludec for EU approval

Novo Nordisk has submitted its long-acting insulin Degludec to the European Medicines Agency (EMA) for marketing authorisation in the EU

Novo Nordisk has submitted its long-acting insulin Degludec to the European Medicines Agency (EMA) for marketing authorisation in the EU.

The insulin, which has been developed for both type 1 and type 2 patients, demonstrated efficacy under stressed frequencies of injection, as presented at the European Association for the Study of Diabetes (EASD) meeting earlier in September.

Degludec showed a reduction in the blood sugar level of patients with type 2 diabetes, even when doses were given once-daily up to 40 hours apart. This was in comparison to an already approved insulin glargine that was given to patients once-daily at a specific time of day according to its label instructions.

Professor David Matthews, Professor of Diabetic Medicine at the University of Oxford, UK, said the results were of potential benefit for patients as they would be able to sustain low blood sugar levels even if they missed an injection the previous day.

Novo also submitted DegludecPlus for approval by the EMA. DegludecPlus is a combination of Degludec and Novo's existing bolus insulin NovoLog.

Novo is still to submit the products for authorisation in the US and Japan.

27th September 2011

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