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CHMP recommends Novo’s insulin extensions

The European Committee for Medicinal Products for Human Use (CHMP) has recommended that approval for Novo Nordisk's insulin Levemir be expanded

The European Committee for Medicinal Products for Human Use (CHMP) has recommended that Novo Nordisk's insulin Levemir (insulin detemir) should have its marketing approval expanded to cover two extra indications.

The body, which acts an advisory board to the European Medicines Agency (EMA), adopted a position opinion on the use of the insulin as an add-on therapy to GLP-1 analogue, Victoza (liraglutide) in combination with metformin patients in type 2 diabetes and also recommended the drug for use in children with type 1 diabetes aged two to five years.

Levemir is currently available as a treatment for type 1 diabetes in adults, adolescents and children aged 6 - 17 years.

The Victoza-related recommendation is based on a 52-week phase III trial that indicated patients randomised to add on Levemir to Victoza and metformin after 26 weeks had further reductions in blood sugar levels than patients just on Victoza and metformin.

The paediatric approval is based on a study that found children aged two-to-five years treated with insulin detemir plus the fast-acting insulin analogue, insulin aspart, experienced lower rates of hypoglycaemia compared to those taking human basal insulin.

Novo said it expected the European Commission to extend marketing authorisation for Levemir in both areas in the coming months.

26th September 2011

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