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FDAnews Drug Daily Bulletin

Baxter Wins New U.S. Indication for Hemophilia Drug

Dec. 23, 2013

Baxter’s hemophilia treatment Feiba has been granted a new indication by the FDA to treat certain patients with hemophilia A and B via infusion. The new indication is aimed at reducing the number of bleeds among patients who have developed inhibitors, the drugmaker says.

The agency’s decision comes on the heels of a Phase III trial in which patients treated with Feiba showed a 72 percent decrease in median annual bleed rate when compared with patients on an on-demand treatment regimen. An additional crossover study published in the New England Journal of Medicine showed that patients using Feiba prophylaxis bled 62 percent less than patients on the other treatment plan.

VH and NF versions of the Feiba system have been available in the U.S. for years as an on-demand treatment. — Lena Freund