Biogen Idec's Hemophilia Drug Eloctate Gets FDA Approval

By Dow Jones Business News, 
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By Josh Beckerman

The U.S. Food and Drug Administration has approved Biogen Idec Inc.'s ( BIIB ) Eloctate drug for adults and children with Hemophilia A.

Under a partnership with Swedish Orphan Biovitrum, or Sobi, Biogen is leading development and has manufacturing rights, and Sobi has the right to assume final development and commercialization in Europe, Russia, the Middle East and Northern Africa.

Biogen said it expects the drug will be commercially available in the U.S. in July.

The FDA approval is the first for Eloctate, which is under review in several countries including Canada, Australia and Japan.

The companies announced in April that a Phase 3 study of the drug in children under 12 achieved its primary objectives.

Eloctate helps control and prevent bleeding, manage bleeding during surgical procedures, and prevent or reduce the frequency of bleeding episodes.

Write to Josh Beckerman at josh.beckerman@wsj.com

Subscribe to WSJ: http://online.wsj.com?mod=djnwires


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  06-06-141721ET
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