Health Canada OKs Biogen Idec’s hemophilia A therapy Eloctate

Canadian regulator Health Canada has approved US Biotech major Biogen Idec’s (Nasdaq: BIIB) Eloctate (antihemophilic factor [recombinant BDD], Fc fusion protein) for the control and prevention of bleeding episodes and routine prophylaxis in adults and children aged 12 and older with hemophilia A.

Eloctate, which is partnered with Swedish Orphan Biovitrum (STO: SOBI), is the first recombinant hemophilia A therapy with prolonged circulation in the body. It is the only treatment for hemophilia A to reduce the frequency of bleeding episodes via prophylactic regimens of either every three to five days, or once-weekly infusions. Eloctate offers people with hemophilia A the potential to extend the interval between prophylactic infusions.1

"Prophylactic treatment is recommended for people with severe hemophilia; however, following a protective regimen can be a burden due to the frequency of infusions required," said Jean St-Louis, director of the Hemostasis Programs of the CHU Sainte-Justine and the Maisonneuve-Rosemont Hospital. "Health Canada's approval of Eloctate provides people with hemophilia A an important new option in maintaining a prophylactic regimen, which may help alleviate this burden, and enable individuals to achieve their target factor levels with less frequent prophylactic dosing than traditional therapy," he noted.