HAE in the News

The articles listed below are various press releases on Hereditary Angioedema

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KALBITOR® (ecallantide) Now Commercially Available
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dyax Corp. (NASDAQ:DYAX) announced today that KALBITOR® (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older is now commercially available in the United States. ...more


Dyax Announces FDA Approval of KALBITOR® (ecallantide) for the Treatment of Acute Attacks of Hereditary Angioedema in Patients 16 Years of Age and Older
CAMBRIDGE, Mass. - (Business Wire) Dyax Corp. (NASDAQ:DYAX) announced today that the U.S. Food and Drug Administration (FDA) has granted approval for KALBITOR® (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older. ...more


DX-88 (ecallantide) Demonstrated Relief of Symptoms in Hereditary Angioedema Acute Attacks in All Attack Locations
An analysis demonstrating the ability of DX-88 (ecallantide) to resolve symptoms of acute hereditary angioedema (HAE) attacks in all anatomic locations and to sustain effect will be presented in an oral presentation this week at the American College of Allergy, Asthma and Immunology (ACAAI) 2009 Annual Meeting in Miami Beach. This evaluation, and two others to be presented, highlight efficacy and safety analyses from the integrated analysis of the two Phase 3 placebo-controlled trials, EDEMA3® and EDEMA4®, of DX-88, the lead product candidate of Dyax Corp. (NASDAQ:DYAX), for the treatment of acute attacks of HAE. ...more


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.
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. ...more


FDA Approves Berinert to Treat Abdominal Attacks, Facial Swelling Associated With Hereditary Angioedema
The U.S. Food and Drug Administration today approved Berinert, the first treatment for acute abdominal attacks and facial swelling associated with a rare and potentially life-threatening genetic disease called hereditary angioedema (HAE).

Berinert is approved for adults and adolescents with HAE, which can occur spontaneously or during stress, surgery, or infection in patients diagnosed with HAE. The symptoms during abdominal attacks include severe abdominal pain, nausea, vomiting, cramps, and diarrhea. ...more


New Marketing Authorization Application for Rhucin submitted to the EMEA by Pharming
Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today announced that it has submitted the Marketing Authorization Application (MAA) for Rhucin for the treatment of acute attacks of Hereditary Angioedema (HAE) to the European Medicines Agency (EMEA). ...more


Pharming gets positive results from final analysis of Rhucin studies
Biotech company Pharming Group NV announced that, as part of the activities for the regulatory submission files, it has now also completed the final analysis of its Rhucin randomised placebo-controlled studies. The results confirm the positive and consistent efficacy and safety of Rhucin in the treatment of acute angioedema attacks in patients with Hereditary Angioedema (HAE). ...more


Dyax Announces FDA Accepts for Review the Complete Response Submission for DX-88 in Hereditary Angioedema
Dyax Corp. (NASDAQ:DYAX) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s submission in response to the FDA’s March 2009 Complete Response letter which outlined requirements for approval of DX-88 for the treatment of acute attacks of hereditary angioedema (HAE). In connection with the acceptance, the FDA assigned Dyax’s BLA a new Prescription Drug User Fee Act (PDUFA) action date of December 1, 2009. ...more


ViroPharma receives complete response letter for Cinryze™ Supplemental Biologics License Application for acute treatment of ...
EXTON, Pa., June 4, 2009 -- ViroPharma Incorporated (Nasdaq: VPHM) today announced that it has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) related to its supplemental Biologics License Application (sBLA) for Cinryze™ (C1 esterase inhibitor [human]) as a treatment for acute attacks of hereditary angioedema (HAE). The FDA has requested an additional clinical study, due to their opinion that the placebo controlled study submitted in support of the sBLA lacked robustness. In the Complete Response letter, the FDA cited no safety concerns related to acute treatment with Cinryze in the clinical studies. ...more


Dyax Says FDA Seek More Details On DX-88
Thursday, Dyax Corp. (DYAX: News ), said it has received a complete response letter from the U.S. Food and Drug Administration, seeking additional details regarding the Biologic License Application for DX-88 for the treatment of acute attacks of hereditary angioedema. ...more


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