The US Food and Drug Administration (FDA) has approved CSL Behring's Berinert, as the first treatment for acute abdominal attacks and facial swelling associated with the rare and life-threatening genetic disease hereditary angioedema (HAE).
Berinert has been approved for use in adults and adolescents with HAE, which can occur spontaneously or during stress, surgery or infection, causing severe abdominal pain, nausea, vomiting, cramps and diarrhoea.
The FDA's Center for Biologics Evaluation and Research acting director Karen Midthun said that Berinert will enhance the treatment options for individuals who experience acute abdominal attacks and facial swelling associated with HAE.
Berinert is a protein-based product derived from human plasma, which regulates the clotting and inflammatory reactions that can lead to local tissue swelling.
Approval was granted on the basis of successful clinical trials, which proved the efficacy of Berinert in 124 adults and adolescents with C1 esterase inhibitor deficiency.
Side affects include increased pain and subsequent HAE attack, headache, abdominal pain, nausea, muscle spasms, pain, diarrhoea and vomiting.