FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

New Hemophilia Drug Gets FDA Nod

Nov. 22, 2017
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The FDA approved a new preventative treatment for hemophilia from Genentech.

The medication, Hemlibra (emicizumab-kxwh), is injected weekly to reduce the frequency of bleeding episodes in children and adults with hemophilia A with factor VIII inhibitors.

Hemlibra is a biologic designated as an orphan drug by the FDA. The use of the four-letter suffix follows a policy announced in January for branded biologics and biosimilars, with this usage one of the first for an approved biologic.

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