Berinert is a pasteurized, nanofiltered therapy indicated for the treatment of acute attacks of hereditary angioedema (HAE), a rare and potentially fatal genetic disorder.
According to the company, patients can now self-administer Berinert by intravenous infusion with appropriate training from a physician.
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.
Intervention with Berinert at the onset of an abdominal or facial HAE attack has been shown to provide 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, the company said.