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CSL Behring Announces FDA Approval of Berinert®, First and Only Therapy Approved for the Treatment of Acute Abdominal and Facial Attacks of Hereditary Angioedema in U.S.

CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Berinert® C1-Esterase Inhibitor, Human for the treatment of acute abdominal or facial attacks of hereditary angioedema (HAE), a rare and serious genetic disorder, in adult and adolescent patients. Berinert is the first and only therapy approved for this indication in the U.S. The approval is based on the results of the phase II/III prospective, double-blind placebo-controlled International Multi-center Prospective Angioedema C1-Inhibitor Trial (I.M.P.A.C.T.), which studied the efficacy and safety of C1-inhibitor (C1-INH) concentrate. The safety and efficacy of Berinert for prophylactic therapy have not been established.
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CSL Behring Launches Berinert® Expert Network (B.E.N.™), Support System for Hereditary Angioedema Healthcare Providers, Patients and Caregivers

CSL Behring announced today the launch of the Berinert® Expert Network (B.E.N.™ ), a full-service support program for healthcare providers and for hereditary angioedema (HAE) patients and their caregivers. HAE is a rare and serious disorder that causes swelling in various parts of the body. In October the U.S. Food and Drug Administration (FDA) granted marketing approval for Berinert C1-Esterase Inhibitor, Human for the treatment of acute abdominal or facial attacks of HAE, a rare and serious genetic disorder, in adult and adolescent patients. The safety and efficacy of Berinert for prophylactic therapy have not been established. Berinert is now available through specialty pharmacies and distributors in the United States.
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Study Shows C1-Esterase Inhibitor Concentrate Rapidly Relieves Acute, Successive Attacks of Hereditary Angioedema at All Body Sites

C1-esterase inhibitor (C1-INH) concentrate is an effective, well-tolerated therapy that rapidly relieves acute swelling attacks and successive attacks at any body location in patients with hereditary angioedema (HAE), a rare and serious genetic disorder, according to data presented today at the 2010 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. Additional pharmacokinetic data presented at the meeting confirms that C1-INH concentrate has a longer half-life than other treatment options for HAE, which protects patients from rebound attacks.
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Surveys Reveal High Frequency of Prodromal Symptoms Prior to Acute Hereditary Angioedema Attacks

Patients with hereditary angioedema (HAE) experience prodromal or early warning symptoms before nearly three-quarters of their HAE attacks, according to survey findings presented today at the 2010 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. According to researchers, this high frequency suggests that prodromal symptoms may reliably indicate when to initiate treatment to help prevent an acute HAE attack.
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