FDA Approves CSL Behring’s Berinert

The FDA has approved CSL Behring’s Berinert for the treatment of acute abdominal attacks and facial swelling associated with hereditary angioedema (HAE). Berinert, a protein product derived from human plasma, regulates clotting and inflammatory reactions that, when impaired, can lead to local tissue swelling.

In a clinical trial of 124 adults and adolescents with C1 esterase, inhibitor deficiency, Berinert was shown to be effective at treating the symptoms of acute moderate-to-severe abdominal attacks and facial swelling in patients with HAE.

Reportedly, Berinert is approved for adults and adolescents with HAE, which can occur spontaneously or during stress, surgery, or infection in patients diagnosed with HAE. The symptoms during abdominal attacks include severe abdominal pain, nausea, vomiting, cramps, and diarrhea.

Moreover, Berinert is contraindicated in patients with a history of life-threatening hypersensitivity reaction to C1 esterase inhibitor preparations.

Karen Midthun, acting director of center for biologics evaluation and research at FDA, said: “Berinert will enhance the treatment options for individuals who experience acute abdominal attacks and facial swelling associated with hereditary angioedema.”