Oct. 12 (HealthDay News) -- Berinert (C1-esterase inhibitor) has been approved by the U.S. Food and Drug Administration as the first sanctioned treatment for a rare genetic disease called hereditary angiodema (HAE), the agency said in a news release.
The drug is approved for adults and adolescents who have symptoms of HAE, including painful abdominal attacks and facial swelling. Symptoms may develop for no apparent reason, or during stress, surgery or infection, the FDA said. The drug, a protein derived from human plasma, was deemed safe and effective in a clinical trial of 124 adults and adolescents with HAE.
People with a life-threatening sensitivity to C1 esterase inhibitor preparations shouldn't take Berinert. The most serious adverse reactions reported during clinical testing included an increase in the severity of HAE-associated pain, headache, nausea, muscle spasms, diarrhea and vomiting, the agency said.
Berinert is produced by the German drug maker CSL Behring Inc.