Novo Nordisk's Tresiba, Ryzodeg garner European approval

Novo Nordisk on Monday announced that the European Commission approved Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart) for the treatment of diabetes in adults. The company said it expects to launch Tresiba in the UK and Denmark during the first half of this year and in other European markets throughout the rest of 2013 and 2014, with Ryzodeg to be launched approximately one year later.

In studies supporting the marketing application for Tresiba, the once-daily, ultra-long-acting basal insulin analogue demonstrated a significantly lower risk of overall and nocturnal hypoglycaemia, when compared to Sanofi's Lantus (insulin glargine), while achieving equivalent reductions in HbA1c. The company added that with a duration of action beyond 42 hours, the therapy is the first basal insulin to offer patients the possibility of adjusting the time of injection when needed.

Meanwhile, in a study supporting the filing for Ryzodeg, the combination treatment demonstrated a significantly lower risk of overall and nocturnal hypoglycaemia compared to Novo Nordisk's NovoMix (biphasic insulin aspart), while achieving equivalent reductions in HbA1c. Ryzodeg, which contains the once-daily basal insulin degludec in a soluble formulation with insulin aspart, can be administered once or twice daily. Novo Nordisk noted that both products will be available in the prefilled FlexTouch insulin pen.

In September last year, the Japanese Ministry of Health, Labour and Welfare approved Tresiba, with Ryzodeg being cleared in December, while in the US, an FDA advisory committee recently voted 8-4 to recommend approval of the therapies.

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