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News & Events
Emicizumab-kxwh (HEMLIBRA, Genentech) was approved for use by the US Food and Drug Administration on November 16, 2017 for individuals with hemophilia A and inhibitors.
The National Hemophilia Foundation’s (NHF) Medical and Scientific Advisory Council (MASAC) has issued the latest revision to their most comprehensive treatment document, which is periodically updated to provide information on current bleeding disorder therapies available in the U.S. The new document, which is listed below, was approved by MASAC on April 19, 2018.
The designation is for people with hemophilia A without inhibitors.
Genentech has announced that the U.S. Food and Drug Administration (FDA) has granted “breakthrough” therapy designation to HEMLIBRA® for people with hemophilia A, without inhibitors. Breakthrough drugs are put on a fast-track approval program and given intensive guidance from the FDA. The therapy was co-developed by Genentech, Chugai and Roche.
NHF is expanding its work with the bleeding disorders community around the world.