ROCKVILLE, Md. The Food and Drug Administration has approved a drug designed to treat symptoms associated with a rare and potentially fatal genetic disease.
The agency announced the approval of Marburg, Germany-based CSL Behring’s Berinert (C1 esterase inhibitor), for the treatment of abdominal attacks and facial swelling associated with hereditary angioedema in adolescents and adults. The drug is a protein product derived from human plasma.
“Berinert will enhance the treatment options for individuals who experience acute abdominal attacks and facial swelling associated with hereditary angioedema,” FDA Center for Biologics Evaluation and Research acting director Karen Midthun said in a statement.