Navigation Links
CSL Behring Receives FDA Approval of Expanded Label on Berinert® for Self-administration and Treatment of Acute Laryngeal Attacks of Hereditary Angioedema
Date:1/3/2012

KING OF PRUSSIA, Pa., Jan. 3, 2012 /PRNewswire/ -- CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for self-administration of Berinert®, C1 Esterase Inhibitor (Human),  a pasteurized, nanofiltered therapy indicated for the treatment of acute attacks of hereditary angioedema (HAE), a rare and potentially fatal genetic disorder. With appropriate training from a physician, patients can now self-administer Berinert by intravenous infusion. As part of the label expansion, Berinert is now also indicated to treat life-threatening laryngeal HAE attacks, as well as facial and abdominal attacks.

"Once the early signs of an HAE attack begin to emerge, any delay in starting treatment can increase the severity of that attack. This can lead to a patient needing to be hospitalized," said Dr. Bruce Zuraw, Professor of Medicine-in-Residence, University of California, San Diego, School of Medicine. "However, if a patient self-administers therapy as soon as symptoms begin to appear, these problems can usually be averted. Clearly, this label expansion for Berinert is an extremely important advance in the on-demand treatment of attacks of HAE. Home-based self-administration provides HAE patients with a great opportunity to improve their lives."

Intervention with Berinert at the onset of an abdominal or facial HAE attack has been shown to provide significantly faster relief to a patient (median onset of relief of 48 minutes in clinical trials, versus more than four hours in placebo group).  In a non-placebo extension study, the use of Berinert to treat laryngeal attacks provided a median onset of relief of 15 minutes, which is significant due to the potentially life-threatening nature of these attacks.

CSL Behring has marketed Berinert in the United States for the treatment of acute abdominal or facial attacks of HAE in adolescent and adult patients since its FDA approval in October 2009.  Approval of the expanded label for Berinert follows years of clinical experience in Europe establishing the safety and efficacy of self-administration of C1-INH therapy. For further information about Berinert, please visit www.berinert.com.

About Hereditary Angioedema

HAE is a rare genetic disorder caused by a deficiency of C1-INH. It is inherited in an autosomal dominant manner. Symptoms of HAE include episodes of edema, or swelling, in the face, abdomen, larynx and extremities. Patients who have abdominal attacks of HAE can experience episodes of extreme pain, diarrhea, nausea and vomiting caused by swelling of the intestinal wall. HAE attacks that involve the face or throat 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.

About Berinert®

Berinert, C1 Esterase Inhibitor (Human),  a pasteurized, nanofiltered plasma-derived intravenous therapy, treats acute facial, abdominal and laryngeal hereditary angioedema (HAE) symptoms by providing C1-INH deficient adult and adolescent patients with the missing human protein. Without C1-INH, people with HAE suffer from recurrent episodes of rapid swelling of areas of the skin and underlying tissues including the face, mouth, throat and abdomen. CSL Behring has marketed its pasteurized and nanofiltered C1-esterase inhibitor concentrate, Berinert, in Germany for more than 30 years. The product is also approved and marketed in 23 other European countries, the United States, Australia, Canada, Israel, Argentina, Japan and South Korea.

The safety and efficacy of Berinert for prophylactic therapy have not been established. Berinert is contraindicated in individuals with a history of life-threatening systemic reactions, to C1 esterase inhibitor preparations, including anaphylaxis. The most serious adverse reaction reported in subjects who received Berinert in clinical studies was an increase in the severity of pain associated with HAE. In placebo-controlled clinical trial, dysgeusia was the most common adverse reaction reported in over 4 percent of subjects who received Berinert and more frequently than in placebo group. Thrombotic events have been reported in patients receiving C1 esterase inhibitor product, including Berinert, at the recommended dose as well as when used off-label or at higher-than-labeled doses.

Berinert is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.  Please see full prescribing information for Berinert.

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, hereditary angioedema, haemophilia, 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, CSL Plasma. CSL Behring is a subsidiary of CSL Limited, a biopharmaceutical company with headquarters in Melbourne, Australia. For more information, visit 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

 

 

 


'/>"/>
SOURCE CSL Behring
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. CSL Behring Reaches Primary Endpoint in Clinical Study of C1-INH for Treatment of Hereditary Angioedema
2. CSL Behring Study in Animal Models Shows Feasibility of Developing a Half-Life Extended Recombinant FVIIa that Retains Biologic Activity
3. CSL Behring Submits BLA Requesting Approval of C1-Esterase Inhibitor for the Treatment of Hereditary Angioedema
4. Over $10 Million of CSL Behrings Privigen Was Sold in the U.S. During the Third Quarter of 2008
5. CSL Behring Receives Orphan-Drug Exclusivity for RiaSTAP(TM), First and Only Approved Treatment of Acute Bleeding Episodes in Patients with Congenital Fibrinogen Deficiency
6. CSL Behring Announces FDA Approval of Berinert(R), First and Only Therapy Approved for the Treatment of Acute Abdominal and Facial Attacks of Hereditary Angioedema in U.S.
7. CSL Behring Announces Completion of National Marketing Authorizations of Berinert® After MRP in 23 European Countries
8. CSL Behring Medical Product Donation Helps Meet Critical Need for Ongoing Cholera Relief Effort in Haiti
9. CSL Behring Marks World Hemophilia Day with Coagulation Factor Donation to World Federation of Hemophilia
10. National Organization for Rare Disorders Presents CSL Behring With 2011 Corporate Award
11. CSL Behring Receives EU Orphan Drug Designations for rVIIa-FP for Hemophilia A and B Treatment
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/21/2017)... 21, 2017 Cadence Design Systems, Inc. (NASDAQ: ... Tensilica ® Fusion F1 DSP is part of the ... The licensable IP targets SoCs designed for battery-powered sensor nodes ... leveraged the Fusion F1 DSP both to implement the IEEE ... trigger, audio identification and sensor fusion on a single DSP. ...
(Date:2/21/2017)... Research and Markets has announced the addition of the "Liver Cirrhosis ... ... Cirrhosis Drugs Price Analysis and Strategies - 2016, provides drug pricing data ... answers the following questions: What are the key ... positioned in the Global Liver Cirrhosis market? What are ...
(Date:2/21/2017)... Research and Markets has announced the addition of ... to their offering. ... latest research Rosacea Drugs Price Analysis and Strategies - 2016, provides drug ... research answers the following questions: What are the ... positioned in the Global Rosacea market? What are the ...
Breaking Medicine Technology:
(Date:2/21/2017)... Atlanta, GA (PRWEB) , ... February 21, 2017 ... ... firm, announced the acquisition of the predictive analytic firm Predixion’s Healthcare IT practice. ... of investment and is backed by giants including Accenture, GE Ventures, ...
(Date:2/21/2017)... ... February 21, 2017 , ... Along with Valentine’s Day, ... and make small changes that can lead to a lifetime of heart health. ... a cardiac emergency. , The Athletic Trainers’ Society of New Jersey (ATSNJ) ...
(Date:2/20/2017)... (PRWEB) , ... February 20, 2017 , ... Silverado today ... Healthcare to open and operate a state-of-the-art memory care community in Alexandria, Virginia. The ... on a site just outside of Old Town. , The three-story community with ...
(Date:2/20/2017)... ... 20, 2017 , ... The StayWell Company and VUCA Health ... patient health risks, foster behavior change and improve health literacy among patients. VUCA Health, ... a demonstration of its video capability at StayWell booth 3443 during HiMSS. , ...
(Date:2/20/2017)... ... February 20, 2017 , ... Houston dentist , Dr. ... care at his office, Antoine Dental Center. Emergency dentistry encompasses many treatments for ... at risk for serious complications and often experience severe pain. Not only does ...
Breaking Medicine News(10 mins):