FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

EU Panel Recommends Roche Hemophilia Drug

Jan. 30, 2018

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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