Alexion's Soliris improves PNH anemia, BLA filed

By Lisa Kerner

Charlotte, N.C., Sept. 20 - Alexion Pharmaceutical Inc.'s novel monoclonal antibody drug Soliris significantly reduced symptoms of paroxysmal nocturnal hemoglobinuria, a form of anemia, compared with a placebo, according to the results of the Triumph study published in The New England Journal of Medicine.

Data show that anemia was improved in the group of patients receiving Soliris, who required a median of 0 units of red blood cells transfused compared with a median of 10 units per patient required in the placebo group.

The study enrolled 87 patients at 45 sites in the United States, Canada, Europe and Australia.

The Cheshire, Conn., biotechnology company also submitted a Biologics License Application with the Food and Drug Administration for Soliris in the paroxysmal nocturnal hemoglobinuria indication.

"We look forward to working with the FDA as it reviews our application and we remain on track to submit a Marketing Authorization Application in Europe by the end of this year," chief executive officer Leonard Bell said in a news release.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.