FDA approves CSL Behring's Berinert for treatment of HAE attacks

CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for self-administration of Berinert®, C1 Esterase Inhibitor (Human),  a pasteurized, nanofiltered therapy indicated for the treatment of acute attacks of hereditary angioedema (HAE), a rare and potentially fatal genetic disorder. 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.

"Once the early signs of an HAE attack begin to emerge, any delay in starting treatment can increase the severity of that attack. This can lead to a patient needing to be hospitalized," said Dr. Bruce Zuraw, Professor of Medicine-in-Residence, University of California, San Diego, School of Medicine. "However, if a patient self-administers therapy as soon as symptoms begin to appear, these problems can usually be averted. Clearly, this label expansion for Berinert is an extremely important advance in the on-demand treatment of attacks of HAE. Home-based self-administration provides HAE patients with a great opportunity to improve their lives."

Intervention with Berinert at the onset of an abdominal or facial HAE attack has been shown to provide significantly faster relief to a patient (median onset of relief of 48 minutes in clinical trials, 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, which is significant due to the potentially life-threatening nature of these attacks.

Source:

CSL Behring

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