CSL Behring's Berinert OKed in Europe for short-term prophylaxis in HAE

Germany-based CSL Behring, a unit of Australia’s CSL Ltd (ASX: CSL) says that European health authorities have approved an extended use of Berinert, a C1-esterase inhibitor (C1-INH) concentrate, for pre-procedure prevention (short-term prophylaxis) of acute episodes of hereditary angioedema (HAE), in adult and pediatric patients undergoing medical, dental or surgical procedures. HAE is a rare, serious and sometimes life-threatening genetic disorder.

"This important approval supports the established treatment recommendations for the use of C1-INH concentrate as first-line therapy for the prevention of potentially life-threatening HAE attacks triggered by surgical or dental procedures," said Konrad Bork, a professor at the Department of Dermatology, Johannes Gutenberg University, Mainz, Germany.

"I am very pleased, as with this expanded indication of Berinert, we now have the first approved preventive therapy to protect children with this hereditary condition who are undergoing surgery," commented Inmaculada Martinez-Saguer, of the Hamophilie Zentrum Rhein Main, Morfelden-Walldorf, Germany.