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Home Industry News Biogen Idec receives EU backing for paediatric trial of haemophilia drug

Biogen Idec receives EU backing for paediatric trial of haemophilia drug

10th May 2011

Biogen Idec has been given a positive opinion by European healthcare regulators on a planned paediatric trial of a potentially promising new haemophilia B treatment.

In association with partner Swedish Orphan Biovitrum, the company is planning to initiate a global investigational plan of their new long-lasting, fully-recombinant Factor IX Fc fusion protein among previously treated patients aged below 12 years of age.

Having received approval from the European Medicines Agency's Paediatric Committee, the companies will seek to begin the study when sufficient data has been collated from a trial involving adult patients.

Results from this trial will be used to support a marketing authorisation application for the drug later down the line.

Dr Glenn Pierce, senior vice-president for haemophilia at Biogen Idec, said: "With this opinion and the ongoing phase III trials of our long-lasting Factor IX and Factor VIII programmes, we continue to make progress toward our goal of improving the way haemophilia is treated worldwide."

Last month, the company published its financial report for the first quarter of 2011, during which it experienced a nine percent year-on-year revenue growth.ADNFCR-8000103-ID-800525510-ADNFCR

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