Navigation Links
CSL Behring Submits BLA Requesting Approval of C1-Esterase Inhibitor for the Treatment of Hereditary Angioedema
Date:3/6/2008

Pivotal phase II/III study demonstrates C1-INH is effective treatment for

acute HAE attacks

KING OF PRUSSIA, Pa., March 6 /PRNewswire/ -- 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.

The proposed indication is for the treatment of acute attacks in patients with HAE. Currently, there are no specifically-approved therapies for HAE in North America.

"Submission of the BLA for C1-INH brings CSL Behring one step closer to providing therapy for hereditary angioedema," said Val Romberg, Senior Vice President of Research and Development at CSL Behring. "We are confident that our expertise in developing and manufacturing plasma-derived protein therapies will be advantageous in our pursuit of regulatory approval in the United States."

HAE is a genetic disorder caused by a deficiency of C1-INH which is inherited in an autosomal dominant manner. Symptoms include episodes of edema or swelling in the hands and feet, the face, the abdomen, and/or the larynx. Patients who have abdominal attacks can experience episodes of severe pain, diarrhea, nausea, and vomiting caused by swelling of the intestinal wall. Attacks that involve the face and larynx can result in airway closure, asphyxiation, and, if untreated, death. Diagnosis of HAE requires a blood test to confirm low or abnormal levels of C1-INH. There are estimates of 6,000 to 10,000 or more people with HAE in the United States.

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

CSL Behring manufactures and sells C1-INH concentrate in Germany, Austria, Switzerland, and several other countries under the trade name Berinert(R) P.

About CSL Behring

CSL Behring is a global leader in the plasma protein biotherapeutics industry. Passionate about improving the quality of patients' lives, CSL Behring manufactures and markets a range of safe and effective plasma-derived and recombinant products and related services. The company's therapies are used in the treatment of immune deficiency disorders, hemophilia, von Willebrand disease, other bleeding disorders and inherited emphysema. Other products are used for the prevention of hemolytic diseases in the newborn, in cardiac surgery, organ transplantation and in the treatment of burns. The company also operates one of the world's largest plasma collection networks, ZLB Plasma. CSL Behring is a subsidiary of CSL Limited, a biopharmaceutical company with headquarters in Melbourne, Australia. For more information, visit http://www.cslbehring.com.

Contact:

Sheila A. Burke, Director, Communications & Public Relations

Worldwide Commercial Operations

CSL Behring

610-878-4209 (o)

484-919-2618 (c)

Sheila.Burke@cslbehring.com

Brian Thompson

MCS

908-234-9900 (o)

201-952-5967 (c)

briant@mcspr.com


'/>"/>
SOURCE CSL Behring
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. CSL Behring Study in Animal Models Shows Feasibility of Developing a Half-Life Extended Recombinant FVIIa that Retains Biologic Activity
2. CSL Behring Reaches Primary Endpoint in Clinical Study of C1-INH for Treatment of Hereditary Angioedema
3. Cell Therapeutics, Inc. (CTI) Submits European Marketing Authorization Application for XYOTAX(TM)
4. Gen-Probe Submits U.S. Regulatory Application for Additional Approval of PROCLEIX(R) ULTRIO(R) Blood Screening Assay
5. Pharmion Submits European Marketing Authorization Application (MAA) for Vidaza(R) in Patients with Higher-Risk Myelodysplastic Syndromes (MDS)
6. Takeda Submits New Drug Application for Alogliptin (SYR-322) in the U.S.
7. AstraZeneca Submits sNDAs for SEROQUEL XR(TM) for the Treatment of Bipolar Mania and Bipolar Depression
8. Roche Submits Application for FDA Approval of ACTEMRA(R) for the Treatment of Rheumatoid Arthritis
9. Peregrine Pharmaceuticals Submits Clinical Protocol for New Phase II Trial of Bavituximab in Patients With Metastatic Breast Cancer
10. Vanda Pharmaceuticals Submits Iloperidone New Drug Application
11. Peregrine Pharmaceuticals Submits Clinical Protocol to Initiate Bavituximab Phase II Trial in Patients With Metastatic Breast Cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/20/2017)... 20, 2017  Cogentix Medical, Inc. (NASDAQ: CGNT), ... the Urology, Uro/Gyn and Gynecology markets with innovative ... has joined the Company as Senior Vice President, ... position, Mr. Keswani will report directly to ... "Our organization is delighted that Ash has joined ...
(Date:4/20/2017)... , April 20, 2017  RXi Pharmaceuticals Corporation ... therapeutics that address significant unmet medical needs, today ... the Company,s consumer product development program, based on ... Society for Investigative Dermatology (SID) 76 th ... and promote the sciences relevant to skin health ...
(Date:4/20/2017)... , April 20, 2017  AbbVie (NYSE: ... 99 percent (n=145/146) of chronic hepatitis C virus ... 5 or 6 and compensated cirrhosis (Child-Pugh A) ... (SVR 12 ) with its investigational, pan-genotypic regimen ... rates were seen following 12 weeks of G/P ...
Breaking Medicine Technology:
(Date:4/29/2017)... ... April 29, 2017 , ... TransDark is a set ... one video to the next without having to set a single keyframe in ... to enhance your video production. , TransDark features dynamic transitions that momentarily splits the ...
(Date:4/28/2017)... (PRWEB) , ... April 28, 2017 , ... An April 24th article on ... stunning 180 pounds with the help of a weight loss surgery. The woman, declaring “I ... skin that have been left following her dramatic weight loss. Dr. Feiz & Associates notes ...
(Date:4/28/2017)... , ... April 28, 2017 , ... Beginning in 2017, ... their formulas. This begins with the popular ClearLungs Extra Strength formula. To ensure that ... the formula in the following ways:, , Removal of the ...
(Date:4/28/2017)... ... April 28, 2017 , ... Ushio America ... lamps offer an instant energy-saving solution for F32T8 fluorescent lamps on most instant-start ... ballasts. These 50,000 hour rated lamps utilize the existing electronic ballast, saving labor ...
(Date:4/28/2017)... ... April 28, 2017 , ... From ... College of Urgent Care Medicine will host industry leaders for the annual spring ... help those in the industry adapt to the issues currently affecting urgent care ...
Breaking Medicine News(10 mins):