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 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.
October 12, 2009
Approved for the Treatment of Acute Abdominal and Facial Attacks of
Hereditary Angioedema in U.S.
October 12, 2009
KING OF PRUSSIA, Pa., Oct. 12 /PRNewswire/ -- 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
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