Trade Resources Industry Views CSL Behring Has Obtained Expanded Label Approval for a C1-INH Concentrate

CSL Behring Has Obtained Expanded Label Approval for a C1-INH Concentrate

CSL Behring has obtained expanded label approval for a C1-esterase inhibitor (C1-INH) concentrate, Berinert, for short-term prophylaxis in adults and children with hereditary angioedema (HAE) in 23 European countries.

Berinert is additionally indicated for the treatment of acute HAE attacks at all body sites in adults and children in Europe.

Eligible and trained patients could even self administer the therapy by intravenous infusion.

CSL Behring research and development senior vice president Val Romberg said Berinert will be offered to HAE patients in Europe as preventive therapy for those undergoing procedures like tooth extractions in addition to treatment for acute attacks.

"As part of our ongoing commitment to advance the care and improve the lives of people with rare and serious disorders, we are continuously enhancing our product portfolio with new therapies and approved new uses for established products such as Berinert," Romberg added.

 

Source: http://regulatoryaffairs.pharmaceutical-business-review.com/news/csl-behring-obtains-expanded-label-approval-for-berinert-in-europe-190413
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CSL Behring Obtains Expanded Label Approval for Berinert in Europe