Biogen Idec and Sobi report positive data from paediatric Alprolix study

Biogen Idec and Sobi have announced positive clinical trial data demonstrating the benefits their haemophilia B therapy can offer to paediatric patients.

Top-line results have been reported from the Kids B-LONG phase III clinical study, which evaluated the safety, efficacy and pharmacokinetics of Alprolix in children under age 12 with severe haemophilia B.

The drug was shown to be well-tolerated, with no inhibitors detected during the study. Once-weekly prophylactic dosing with Alprolix resulted in low bleeding rates, thus meeting the primary efficacy endpoint of the trial.

Prophylactic treatment for children with severe haemophilia is recommended because it is associated with proven clinical benefits. However, since frequent administration schedules can be burdensome, a once-weekly treatment option could be greatly beneficial.

Dr Aoife Brennan, vice-president of haematology clinical development at Biogen Idec, said: "This data will enable regulatory filings in Europe later this year, as well as supporting paediatric indications in other countries."

Haemophilia is a key focus area for Biogen Idec. The company is currently also seeking European approval for a new haemophilia A therapy called Elocta.