FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

EU Panel Recommends Roche Hemophilia Drug

Jan. 30, 2018
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The EU’s Committee for Medicinal Products for Human recommended Roche’s Hemlibra (emicizumab) for the treatment of hemophilia in certain patients.

The CHMP expressed a positive opinion for use in the routine treatment of bleeding in hemophilia A patients with factor VIII inhibitors who have built up a resistance to standard treatments.

The approval was based on two clinical studies with statistically significant reductions in treated bleeds compared to previous treatments with a bypassing agent.

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