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This section features CSL Behring news releases that are more than 18 months old. Click the tabs to select releases in your area of interest. Click Resources to find additional background material on CSL Behring.

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Hereditary Angioedema (HAE)

21 July 2008 CSL Behring Submits BLA Requesting Approval of Human Fibrinogen Concentrate for the Treatment of Congenital Bleeding

CSL Behring announced today that it has submitted a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) requesting approval to market its human fibrinogen concentrate in the United States for the treatment of congenital fibrinogen deficiency, a rare bleeding disorder resulting from deficiency of fibrinogen.

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17 April 2008 CSL Behring Submits NDS to Health Canada Requesting Approval of C1-Esterase Inhibitor for the Treatment of Hereditary Angioedema

CSL Behring has filed a new drug submission (NDS) with Health Canada seeking approval to market its C1-esterase inhibitor concentrate in Canada for the treatment of hereditary angioedema (HAE), a rare and serious genetic disorder. The submission is based on the recently completed phase II/III prospective, double-blind placebo-controlled International Multi-center Prospective Angioedema C1-Inhibitor Trial (I.M.P.A.C.T.), the largest HAE trial ever conducted, that studied the efficacy of pasteurized C1-INH concentrate.

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18 March 2008 C1-Esterase Inhibitor Concentrate Rapidly Relieves Abdominal and Facial Attacks in Patients with Hereditary Angioedema, According to Pivotal Study

C1-esterase inhibitor (C1-INH) concentrate is a safe and effective therapy that rapidly relieves acute abdominal and facial swelling attacks in patients with hereditary angioedema (HAE), a rare and serious genetic disorder, according to data presented today at the American Academy of Allergy, Asthma & Immunology (AAAAI) 64th Annual Meeting. Results from the prospective, double-blind International Multi-center Prospective Angioedema C1-Inhibitor Trial (I.M.P.A.C.T. 1), the largest HAE study ever conducted, showed patients receiving C1-INH concentrate had a median time to symptom relief of 30 minutes, versus 90 minutes for patients receiving placebo. Additionally, interim results from I.M.P.A.C.T. 2, also presented at AAAAI, demonstrated for the first time C1-INH replacement therapy’s effectiveness in rapidly relieving HAE attacks in peripheral body locations, such as the hands and feet.

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06 March 2008 CSL Behring Submits BLA Requesting Approval of C1-Esterase Inhibitor for the Treatment of Hereditary Angioedema

CSL Behring has submitted a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) requesting approval to market its C1-esterase inhibitor concentrate in the United States for the treatment of hereditary angioedema (HAE), a rare and serious genetic disorder. The submission is based on the recently completed phase II/III prospective, double-blind placebo-controlled International Multi-center Prospective Angioedema C1-Inhibitor Trial (I.M.P.A.C.T.), the largest HAE trial ever, that studied the efficacy of pasteurized C1-INH concentrate.

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26 November 2007 CSL Behring Reaches Primary Endpoint in Clinical Study of C1-INH for Treatment of Hereditary Angioedema

CSL Behring announced today that it has reached the primary endpoint of a Phase III clinical trial of human pasteurized C1-inhibitor (C1-INH) concentrate to treat patients with hereditary angioedema (HAE), a rare genetic disorder that can lead to painful and sometimes life-threatening attacks of edema (swelling) of the face, airway, abdomen, and extremities.

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