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Lev Takes Steps to Bring Cinryze to Market for the Treatment of HAE
Apr 15, 2008
www.genengnews.com
Lev Pharmaceuticals is making strides to get its hereditary angioedema (HAE) therapy, Cinryze, approved after delays at the FDA and to set itself up for a potential launch. The firm Lev submitted its complete response to the agency’s letter received in February. ...more


AAAAI: New Therapies on Horizon for Angioedema Attacks
Mar 18, 2008
www.medpagetoday.com
...more


FDA Advisory Committee to Review Cinryze
Mar 18, 2008
fdanews.com
The FDA’s Blood Products Advisory Committee will review Lev Pharmaceuticals’ BLA for its lead product candidate, Cinryze, May 2. Cinryze (C1 inhibitor) is for both acute and prophylactic treatment of hereditary angioedema, or C1 inhibitor deficiency, a rare, life-threatening genetic disorder. ...more


Lev Presents Results of Phase III Study Supporting Safety and Efficacy of Cinryze(TM) (C1 inhibitor) as Prophylactic Therapy for
Mar 18, 2008
www.levpharma.com
Lev Pharmaceuticals, Inc. (OTCBB:LEVP.OB) today announced the presentation of results from a Phase III study examining the efficacy and safety of prophylactic use of its C1 inhibitor (C1INH) replacement therapy, Cinryze(TM), in patients with hereditary angioedema (HAE). The findings, presented at the annual meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI), demonstrated that prophylactic use of Cinryze significantly decreases the number of attacks in HAE patients. ...more


C1-Esterase Inhibitor Concentrate Rapidly Relieves Abdominal and Facial Attacks in Patients with Hereditary Angioedema, Accordin
Mar 18, 2008
www.sunherald.com
Data presented at AAAAI 64th Annual Meeting also show that C1-INH is effective treatment for HAE attacks across all body sites ...more


CSL Behring Submits BLA Requesting Approval of C1-Esterase Inhibitor for the Treatment of Hereditary Angioedema
Mar 06, 2008
www.earthtimes.org
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. ...more


Lev Pharmaceuticals Receives Complete Response Letter for Cinryze(TM)
Jan 30, 2008
biz.yahoo.com
Lev Pharmaceuticals, Inc. (OTCBB:LEVP.OB - News) announced today that it has received a complete response letter from the U.S. Food and Drug Administration (FDA) related to its biologics license application (BLA) for Cinryze™ (C1 inhibitor) for both the acute and prophylactic treatment of hereditary angioedema (HAE), or C1 inhibitor deficiency. ...more


FDA Accepts Icatibant NDA
Dec 27, 2007
fdanews.com
German drugmaker Jerini’s new drug application (NDA) for Icatibant in the treatment of hereditary angioedema (HAE) has been accepted by the FDA and granted priority review. ...more


CSL says angioedema drug meets goals of trial
Nov 26, 2007
www.reuters.com
CSL Limited (CSL.AX: Quote, Profile, Research) said on Monday its treatment for hereditary angioedema, a rare genetic disorder that can lead to life-threatening swelling of body tissues, met the primary and secondary goals of a late-stage clinical trial. ...more


Novel Therapies May At Last Bring Relief for U.S. Hereditary Angioedema Patients
Nov 13, 2007
www.newswise.com
Although there is currently no treatment approved by the Federal Drug Administration (FDA) for acute attacks of hereditary angioedema (HAE) – a genetic disease causing swelling of extremities, face and internal organs that can be life-threatening – hope is on the horizon according to a team of experts presenting the latest research at the Annual Meeting of the American College of Allergy, Asthma and Immunology (ACAAI) in Dallas. ...more


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