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CSL Behring’s hereditary angioedema drug Berinert approved in US

Monday, October 12, 2009, 17:57 This news item was posted in Biotech category and has 0 Comments so far.

Berinert is the first and only therapy approved to treat acute abdominal and facial attacks of hereditary angioedema in US

Berinert has been given approval as the first and only therapy for the treatment of acute abdominal or facial attacks of hereditary angioedema by US, said CSL Behring, the maker of the drug.

Berinert C1-Esterase Inhibitor is a plasma-derived intravenous therapy. Berinert treats the fundamental cause of acute facial and abdominal hereditary angioedema symptoms by providing C1-INH deficient adult and adolescent patients with the missing human protein. Without C1-INH, patients with HAE suffer from recurrent episodes of rapid swelling of areas of the skin and underlying tissues including the face, mouth and abdomen.

Berinert has been proved safe and effective in international clinical use in over 400,000 treatments in Germany, Austria, Switzerland, and several other countries where it is manufactured and sold by CSL Behring under the trade name Berinert P.

Berinert is given approval by the USFDA based on the results of the phase II/III prospective, double-blind placebo-controlled International Multi-center Prospective Angioedema C1-Inhibitor Trial (IMPACT), which studied the efficacy and safety of C1-inhibitor (C1-INH) concentrate.

IMPACT analysed 124 hereditary angioedema patients with acute, moderate, or severe abdominal or facial attacks. C1-INH concentrate was administered at two different doses and compared with placebo. The main study endpoints were time to onset of symptom relief from hereditary angioedema attacks, proportion of subjects with worsening clinical HAE symptoms, and safety.

C1-inhibitor concentrate (C1-INH) is effective and safe in rapidly treating acute abdominal and facial skin swellings in adults and adolescents with hereditary angioedema. The study found that the median time to symptom relief was 30 minutes after receiving C1-INH compared with 1.5 hours with a placebo.

The safety and efficacy of Berinert for prophylactic therapy have not been established.

Hereditary angioedema is a rare and serious genetic disorder, in adult and adolescent patients. Hereditary angioedema is a genetic disorder caused by a deficiency of C1-INH and is inherited in an autosomal dominant manner.

Symptoms of hereditary angioedema include episodes of edema or swelling in the face and the abdomen. Patients who have abdominal attacks of hereditary angioedema can experience episodes of severe pain, diarrhea, nausea, and vomiting caused by swelling of the intestinal wall. hereditary angioedema attacks that involve the face can cause painful distortion and painful swelling.  Diagnosis of hereditary angioedema requires a blood test to confirm low or abnormal levels of C1-INH.

6,000 to 10,000 or more people in the U.S are estimated to have hereditary angioedema.

“With the approval of Berinert, healthcare professionals can now provide HAE patients in the US with a safe and effective treatment option that rapidly relieves the symptoms of acute attacks in the face and abdomen,” said Timothy Craig, MD, professor of medicine and pediatrics,Pennsylvania State University Hershey Medical Center.

Berinert has not been evaluated in pregnant women or nursing mothers.Bernert’s benefits of treatment should be weighed against potential risks in pregnant women, and Berinert should be given to nursing mothers only if clearly needed.

Berinert’s safety and efficacy have also not been established in children (ages 0 through 12) or in the geriatric population.

CSL Behring is a leading company in the plasma protein biotherapeutics industry. CSL Behring manufactures and markets a range of safe and effective plasma-derived and recombinant products used in the treatment of immune deficiency disorders, hemophilia, von Willebrand disease, other bleeding disorders and inherited emphysema.

CSL Behring’s other products are used for the prevention of hemolytic diseases in the newborn, in cardiac surgery, organ transplantation and in the treatment of burns.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. CSL Behring is a subsidiary of CSL Limited, a biopharmaceutical company with headquarters in Melbourne, Australia.

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