BERINERT (C1 esterase inhibitor [human]) 500units/vial injection by CSL Behring
CSL Behring announced that the FDA has approved a label expansion for self-administration of Berinert (C1 esterase inhibitor [human]; CSL Behring), a plasma-derived concentrate of C1 esterase inhibitor, for the treatment of acute abdominal or facial attacks of hereditary angioedema (HAE). With appropriate training from a physician, patients can now self-administer Berinert by intravenous infusion. As part of the label expansion, Berinert is now also indicated to treat life-threatening laryngeal HAE attacks, as well as facial and abdominal attacks. This approval was based on data from clinical studies in which intervention with Berinert at the onset of an abdominal or facial HAE attack was shown to provide significantly faster relief (median onset of relief of 48 minutes versus more than four hours in placebo group). In a non-placebo extension study, the use of Berinert to treat laryngeal attacks provided a median onset of relief of 15 minutes.