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June 8, 2014

Biogen Idec receives FDA approval for haemophilia A drug

Biogen Idec has received approval from the US Food and Drug Administration (FDA) for its Eloctate to control and prevent bleeding episodes, perioperative management, as well as routine prophylaxis in adults and children with haemophilia A.

By Mekala ShivaramPrasad

Biogen Idec has received approval from the US Food and Drug Administration (FDA) for its Eloctate to control and prevent bleeding episodes, perioperative management, as well as routine prophylaxis in adults and children with haemophilia A.

The company claims that Eloctate [antihemophilic factor (recombinant), Fc fusion protein] is the first haemophilia A therapy to extend the interval between prophylactic infusions, for both adults and children.

Eloctate reduces the frequency of bleeding episodes with prophylactic infusions every three to five days, offering haemophilia A patients the potential to extend the interval between prophylactic infusions.

The FDA has approved Eloctate based on data from the phase III A-LONG clinical study, and interim pharmacokinetic and safety data from the phase III Kids A-LONG study.

"98% of bleeding episodes were controlled with one or two Eloctate infusions in the study."

The open-label, multi-centre A-LONG study evaluated the safety, efficacy and pharmacokinetics of Eloctate in 165 previously treated males aged 12 years and older with severe haemophilia A.

This study assessed individualised and weekly prophylaxis to reduce or prevent bleeding episodes, and on-demand dosing to treat bleeding episodes.

According to Biogen Idec, the study results demonstrated that adults and adolescents with severe haemophilia A achieved a statistically significant reduction of bleeding episodes in both of the study’s prophylaxis arms, relative to the on-demand treatment arm.

In addition, 98% of bleeding episodes were controlled with one or two Eloctate infusions in the study. No participants in the study developed inhibitors to Eloctate and there were no reports of serious vascular (blood) clots or serious allergic reactions.

Interim safety and pharmacokinetic results from the phase III Kids A-LONG study in 38 boys aged two to 11 years old have supported the paediatric indication for Eloctate. The data showed that the drug was generally well-tolerated and no inhibitors were detected.

Biogen Idec is expected to commercially launch Eloctate in the US in July.

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