Novo Nordisk receives EU label change for NovoMix 30

Novo Nordisk has announced that the EU Commission has altered its label for NovoMix 30 and has approved alterations for the drug’s dosage guidelines. The company says that patients with type-2 diabetes will now be able to use NovoMix, an insulin analogue therapy, once daily. It adds that should the disease become more severe, the guidelines allow for a twice-daily insulin fix.

The EU’s Commission’s findings are based on the findings of two trials. In one of the studies, patients who failed to reach internationally agreed glycaemic targets were given NovoMix 30. After 16 weeks, 41 per cent of patients reached the American Diabetes Association target of HbA less than 7.0 per cent, while 21 per cent achieved the International Diabetes Federation target of HbA less than or equal to 6.5 per cent. This increased to 70 per cent and 52 per cent respectively, after a further 16 week period.

Last week Novo Nordisk reported that sales in its insulin analogues had increased by 60 per cent, boosting total sales increase to almost a quarter. The company also reported a 24 per cent increase in operating profit as the company revealed its first quarterly figures of the year. It is currently pursuing phase III trials of liraglutide, a once-daily analogue. Some studies of this drug have suggested that it does control sugar levels without the associated weight gain with some insulin therapies.

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