HAE in the News

The articles listed below are various press releases on Hereditary Angioedema

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Dyax Announces Final Patient Treated in Second Phase 3 Clinical Trial (EDEMA4®) of DX-88 in Hereditary Angioedema
Dyax Corp. (NASDAQ: DYAX) announced today that it has treated the final patient in its second Phase 3, 96-patient trial of DX-88, known as EDEMA4, for the treatment of acute attacks of hereditary angioedema (HAE). HAE is a rare and life-threatening inflammatory condition for which there is no approved therapy in the United States. ...more


Jerini to Submit Complete Response to the FDA for Icatibant in the Treatment of HAE
Jerini AG (FSE:JI4) announced today that following last week's communication with the US Food and Drug Administration (FDA), the company will submit a complete response to the FDA's not approvable letter for Icatibant in the treatment ofacute attacks of hereditary angioedema (HAE). Jerini's complete response, to be submitted in the next three to four months, will provide the agency with information relating to Icatibant's efficacyin the treatment of HAE. "The FDA has outlined specific areas of concern, which we areplanning to address fully in our complete response," said JensSchneider-Mergener, CEO of Jerini. "Having received very positive feedback from HAE-treating physicians in Europe, Jerini is wellprepared for Icatibant's expected third quarter European product launch ...more


UPDATE 1-Pharming says new test results Rhucin positive
Dutch biotechnology firm Pharming (PHAR.AS: Quote, Profile, Research) said on Monday safety and efficacy results from a north American trial with its key drug Rhucin were positive, igniting 53 percent rally in its shares. ...more


Lev Pharmaceuticals Signs Agreements with CuraScript, CVS Caremark, and FFF Enterprises to Support Cinryze™ Commercialization
Lev Pharmaceuticals, Inc. ("Lev" or the "Company") (OTCBB:LEVP) announced today that it has entered into multi-year agreements with CuraScript, CVS Caremark, and FFF Enterprises to serve as its specialty pharmacy, specialty distribution and patient services partners to support the U.S. commercialization of Cinryze™ [C1 inhibitor, (human)], the company’s investigational treatment for hereditary angioedema (HAE), also known as C1 inhibitor deficiency. ...more


Lev Pharmaceuticals Announces Cinryze(TM) Complete Response Submission Accepted for Review by FDA
Lev Pharmaceuticals, Inc. (OTCBB: LEVP.OB) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Lev's complete response submission for Cinryze(TM: 98.89, -1.59, -1.58%) (C1 inhibitor), the Company's lead product candidate. Lev is seeking marketing approval for Cinryze(TM: 98.89, -1.59, -1.58%) for both the acute and prophylactic treatment of hereditary angioedema (HAE: 55.42, -0.24, -0.43%), also known as C1 inhibitor deficiency. ...more


Lev Announces FDA Advisory Committee Unanimously Recommends Approval of Cinryze(TM) for Hereditary Angioedema
NEW YORK & WASHINGTON - (Business Wire) Lev Pharmaceuticals, Inc. (OTCBB: LEVP) today announced that the Blood Products Advisory Committee to the U.S. Food and Drug Administration (FDA) today voted unanimously that there is sufficient evidence of the safety and efficacy for the approval of Cinryze™ (C1 inhibitor) for the prophylactic treatment of hereditary angioedema (HAE), also known as C1 inhibitor deficiency. ...more


Jerini Drug for Swelling Disease Is Rejected by FDA (Update2)
April 24 (Bloomberg) -- Jerini AG's experimental drug for a life-threatening swelling disease was rejected U.S. regulators, driving the drugmaker to its biggest loss since it began trading in Frankfurt 2 1/2 years ago. The Food and Drug Administration outlined concerns in a so- called non-approvable letter for the medicine, icatibant, Berlin- based Jerini said in a statement on Hugin newswire today. The company didn't disclose the nature of the FDA's concerns and said it plans to review the decision with the agency. ...more


Lev Takes Steps to Bring Cinryze to Market for the Treatment of HAE
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
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FDA Advisory Committee to Review Cinryze
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


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The US Hereditary Angioedema Assoc., Seven Waterfront Plaza, 500 Ala Moana Blvd., Suite 400, Honolulu, HI 96813, (866) 798-5598

The US HAEA's 2010 corporate sponsors