Roche’s Hemlibra Receives FDA Priority Review

June 6, 2018

The FDA granted priority review for Roche’s Hemlibra (emicizumab-kxwh), used for treating adults and children with hemophilia A without factor VIII inhibitors.

The drug was previously granted breakthrough therapy designation by the agency in April 2018 based on data from the firm’s Haven 3 study, which showed a large reduction in treated bleeds and no unexpected or serious adverse events.

Hemlibra is a bispecific factor IXa- and factor X-directed antibody, designed to bring together proteins needed for activating blood coagulation and restoring the blood clotting process for patients with hemophilia A. The preventative treatment can be injected under the skin once weekly.

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