Navigation Links
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.
Date:10/12/2009

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 placebo-controlled International Multi-center Prospective Angioedema C1-Inhibitor Trial (I.M.P.A.C.T.), which studied the efficacy and safety of C1-inhibitor (C1-INH) concentrate. The safety and efficacy of Berinert for prophylactic therapy have not been established.

"The FDA approval of Berinert marks an important milestone in CSL Behring's ongoing commitment to satisfying the unmet needs of patients with rare and serious disorders, such as hereditary angioedema," said Robert Lefebvre, Vice President and General Manager of U.S. Commercial Operations at CSL Behring. "As a leader in developing safe, effective and high-quality therapies, we are pleased to add to our rapidly growing portfolio a proven treatment that can make a positive difference in the lives of HAE patients and their families."

HAE is a genetic disorder caused by a deficiency of C1-INH and is inherited in an autosomal dominant manner. Symptoms of HAE include episodes of edema or swelling in the face and the abdomen. Patients who have abdominal attacks of HAE can experience episodes of severe pain, diarrhea, nausea, and vomiting caused by swelling of the intestinal wall. HAE attacks that involve the face can cause painful distortion and painful swelling. Diagnosis of HAE requires a blood test to confirm low or abn
'/>"/>

SOURCE CSL Behring
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. CSL Behring Receives Orphan-Drug Exclusivity for RiaSTAP(TM), First and Only Approved Treatment of Acute Bleeding Episodes in Patients with Congenital Fibrinogen Deficiency
2. Over $10 Million of CSL Behrings Privigen Was Sold in the U.S. During the Third Quarter of 2008
3. CSL Behring Submits BLA Requesting Approval of C1-Esterase Inhibitor for the Treatment of Hereditary Angioedema
4. CSL Behring Study in Animal Models Shows Feasibility of Developing a Half-Life Extended Recombinant FVIIa that Retains Biologic Activity
5. CSL Behring Reaches Primary Endpoint in Clinical Study of C1-INH for Treatment of Hereditary Angioedema
6. Child Neurology Foundation Announces the Launch of Infantilespasmsinfo.org
7. Elbit Imaging Ltd. Announces Sale of Plaza Centers Shares
8. Onyx Pharmaceuticals Announces Investor Teleconference and Webcast
9. Kensey Nash Corporation Announces Its First Quarter Fiscal Year 2010 Earnings Release Date and Teleconference
10. ADVENTRX Pharmaceuticals Announces Closing of Financing
11. Stereotaxis Announces Pricing of $26 Million Common Stock Offering
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/17/2014)... 2014 /PRNewswire-iReach/ -- ChemImage announced today the ... in the development of imaging technology used ... and diseased tissue that minimizes the learning ... lowers surgical costs and potentially enhances patient ... The clinical and scientific teams at ...
(Date:9/17/2014)... 2014  Decision Resources Group finds that ... for biologic therapy, only a proportion of ... cite patients, discomfort with biological therapy as ... followed by cost-related issues and payer restrictions. ... Janssen Biotech,s Remicade and AbbVie,s Humira are ...
(Date:9/17/2014)... Sept. 17, 2014 Prostate Oncology Specialists ... campaign to educate men about new imaging technology ... the prostate. Annually, a million men undergo random ... rectum. Multi-parametric MRI (MP-MRI) of the prostate gland is ... Men need to be fully informed of their ...
Breaking Medicine Technology:Patient Outcomes Improve When Molecular Chemical Imaging Technology Is Used to Aid Robotic Surgical Procedures, According to New White Paper 2The Majority of Surveyed Gastroenterologists Agree that Biologics Should be Prescribed to More Patients in the Crohn's Disease and Ulcerative Colitis Treatment Paradigm 2The Majority of Surveyed Gastroenterologists Agree that Biologics Should be Prescribed to More Patients in the Crohn's Disease and Ulcerative Colitis Treatment Paradigm 3Prostate Cancer Awareness Month - Stop Random Biopsies 2Prostate Cancer Awareness Month - Stop Random Biopsies 3
... Janam Technologies LLC, a leading ... communicate wirelessly, today announced a new mobile healthcare ... product line with antimicrobial versions of the XM66 and ... provide the healthcare sector with rugged antimicrobial devices ...
... SILVER SPRING, Md., Oct. 14 The U.S. ... that their over-the-counter (OTC) chelation products are unapproved ... violation of federal law to make unproven claims ... chelation products. (Logo:   http://photos.prnewswire.com/prnh/20090824/FDALOGO ) ...
Cached Medicine Technology:Janam Introduces Mobile Healthcare Product Line 2FDA Issues Warnings to Marketers of Unapproved 'Chelation' Products 2FDA Issues Warnings to Marketers of Unapproved 'Chelation' Products 3FDA Issues Warnings to Marketers of Unapproved 'Chelation' Products 4
(Date:9/17/2014)... News) -- Managing diabetes, quitting smoking, controlling high blood ... the risk for dementia -- even late in life, ... Report 2014, commissioned by Alzheimer,s Disease International, revealed that ... percent. The study noted that obesity and an inactive ... as high blood pressure. The researchers suggested ...
(Date:9/17/2014)... an analysis of genetic information among more than 87,000 ... found 23 new genetic variants common differences in ... for prostate cancer. The so-called "meta-analysis," believed to be ... mutations among men in a broad array of ethnic ... ancestry. , The meta-analysis combined information from smaller studies, ...
(Date:9/17/2014)... In a country where 77% of inhabitants ... basis, how can Americans find healthy and fulfilling ways ... Challenge , a 5-day interactive journey to putting stress ... From September 29th – October 3rd, the Hyland’s Stress ... specific topics that promote natural solutions for managing stress. ...
(Date:9/17/2014)... that patients with human papillomavirus (HPV) the ... and neck cancer positive oropharyngeal cancer see ... post-radiation neck dissection than those with HPV-negative oropharyngeal ... findings at the American Society for Radiation Oncology,s ... , "For patients that achieve a complete response, ...
(Date:9/17/2014)... People with facial paralysis are perceived as being less ... language of facial expression, a new study from an ... findings highlight the important role the face plays in ... against those with facial paralysis because of their disability, ... the College of Liberal Arts at Oregon State University. ...
Breaking Medicine News(10 mins):Health News:Healthy Lifestyle Changes Linked to Reduced Risk for Dementia 2Health News:Healthy Lifestyle Changes Linked to Reduced Risk for Dementia 3Health News:Large study reveals new genetic variants that raise risk for prostate cancer 2Health News:Stress Less with the Hyland's 5-Day Stress Challenge 2Health News:Many throat cancer patients can skip neck surgery 2Health News:Lack of facial expression leads to perceptions of unhappiness, new OSU research shows 2Health News:Lack of facial expression leads to perceptions of unhappiness, new OSU research shows 3
... for the first time that human embryonic stem cells ... mature T-cells//, raising hopes for a gene therapy to ... and the Institute for Stem Cell Biology and Medicine ... embryonic stem cells into blood-forming stem cells that in ...
... recent survey it was found that international nurses would need to ... NHS//. ,The step was mainly taken to give jobs ... nurses come to Britain from outside the European Union every year. ... the Philippines and Australia. The rule applies to nurses in bands ...
... 45 seconds, another American has a stroke, caused either by a ... minutes//, one of them will die. ,That's the bad news. ... to find and fix the problems that cause many strokes — ... ever having to open up the skull. ,New technologies, ...
... Dr. Bing-Huei Chen and colleagues it was found that ... form during cooking. ,The research was conduced ... Products (COPs) is produced when cholesterol-rich foods are processed ... the body cells leading to heart disease or cancer. ...
... California Supreme Court said that partners must inform their spouse about ... ,This came down as the court ruling in San Francisco when ... court. The wife accused the ex-husband of transmitting AIDS to her. ... decided that the spouse or partner of a person who has ...
... from the Korea Research Institute of Bioscience and Biotechnology//. ... found a human gene that aids in the growth and spread ... about the discovery and said that it would help in the ... was mainly conducted on mice and the research team found that ...
Cached Medicine News:Health News:T-cells Developed from Human Embryonic Stem Cells 2Health News:Brain Surgery Without the Surgery? 2Health News:Brain Surgery Without the Surgery? 3Health News:Brain Surgery Without the Surgery? 4Health News:Brain Surgery Without the Surgery? 5Health News:Brain Surgery Without the Surgery? 6
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
Medicine Products: