Eloctate [antihemophilic factor (recombinant), Fc fusion protein] is the first haemophilia A therapy with prolonged circulation in the body.
It reduces the frequency of bleeding episodes with prophylactic infusions every three to five days, providing haemophilia A patients the potential to extend the interval between prophylactic infusions.
Biogen Idec chief executive officer George Scangos said the proven ability of ELOCTATE to provide protection from bleeding episodes with prolonged circulation marks the first significant hemophilia A treatment advance in more than 20 years.
"As a company deeply committed to improving the lives of people with hemophilia, we are excited to bring this important innovation to those living with hemophilia A," Scangos said.
The FDA approval is based on results from the global, Phase III A-LONG clinical trial, as well as interim pharmacokinetic (PK) and safety data from the Phase III Kids A-LONG study.
The open-label, multi-centre A-LONG trial assessed the safety, efficacy and pharmacokinetics of Eloctate in 165 previously treated males aged 12 years and older with severe haemophilia A.
The company is expected to commercially launch Eloctate in the US in July 2014.
The recommended starting prophylactic regimen for Eloctate is 50 IU/kg every four days and based on clinical response, the regimen may be adjusted in the range of 25 to 65 IU/kg and every three to five days.