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Hereditary Angioedema Blog

Related terms: Quincke's disease, HAE

FDA Approves Ruconest for Hereditary Angioedema

Posted 8 days ago by Drugs.com

July 17, 2014 – The U.S. Food and Drug Administration yesterday approved Ruconest, the first recombinant C1-Esterase Inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE). Hereditary angioedema, which is caused by having insufficient amounts of a plasma protein called C1-esterase inhibitor, affects approximately 6,000 to 10,000 people in the United States. People with HAE can develop rapid swelling of the hands, feet, limbs, face, intestinal tract, or airway. These acute attacks of swelling can occur spontaneously, or can be triggered by stress, surgery or infection. Swelling of the airway is potentially fatal without immediate treatment. “Hereditary angioedema is a rare and potentially life-threatening disease,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “Today’s approv ... Read more

Related support groups: Angioedema, Hereditary Angioedema, C1 Inhibitor (Human)

Ruconest Approved for Rare Genetic Disease

Posted 8 days ago by Drugs.com

THURSDAY, July 17, 2014 – Ruconest has been approved by the U.S. Food and Drug Administration to treat hereditary angioedema, a genetic disease that leads to sudden and potentially fatal swelling of the hands, feet, limbs, face, intestinal tract or airways. The disease, affecting as many as 10,000 people in the United States, is caused by the body's inability to produce enough of a plasma protein called C1-esterase inhibitor. The remedy is produced from the milk of genetically-modified rabbits, the FDA said Thursday in a news release. Ruconest was evaluated in a clinical study of 44 adults and adolescents with hereditary angioedema. The most common side effects recorded were headache, nausea and diarrhea. Ruconest is manufactured by the Netherlands-based Pharming Group NV, and will be distributed by a subsidiary of Salix Pharmaceuticals, based in Raleigh, NC. More information The FDA ... Read more

Related support groups: Angioedema, Hereditary Angioedema

FDA Approves Expanded Use of Kalbitor for the Treatment of HAE to Patients 12 Years of Age and Older

Posted 7 Apr 2014 by Drugs.com

BURLINGTON, Mass.--(BUSINESS WIRE)-- Dyax Corp. (NASDAQ:DYAX) today announced that the U.S. Food and Drug Administration (FDA) has approved an expansion of the indication for Kalbitor (ecallantide), a peptide inhibitor of plasma kallikrein used in the treatment of acute hereditary angioedema (HAE) attacks, to include patients 12 years of age and older. With this approval, KALBITOR is the first and only subcutaneous therapy available to treat acute attacks of HAE in patients 12 years of age and older. Kalbitor is also the only therapy that is not purified from human plasma that has been approved to treat this patient group. The FDA approval of this label expansion for Kalbitor is supported by the results from two previously completed Phase 3 placebo-controlled clinical studies, known as EDEMA3® and EDEMA4® as well as the results of study DX-88/19, which was ongoing at the time of the o ... Read more

Related support groups: Hereditary Angioedema, Kalbitor, Ecallantide

FDA Approves Expanded Use of Kalbitor for the Treatment of HAE to Patients 12 Years of Age and Older

Posted 7 Apr 2014 by Drugs.com

BURLINGTON, Mass.--(BUSINESS WIRE)-- Dyax Corp. (NASDAQ:DYAX) today announced that the U.S. Food and Drug Administration (FDA) has approved an expansion of the indication for Kalbitor (ecallantide), a peptide inhibitor of plasma kallikrein used in the treatment of acute hereditary angioedema (HAE) attacks, to include patients 12 years of age and older. With this approval, KALBITOR is the first and only subcutaneous therapy available to treat acute attacks of HAE in patients 12 years of age and older. Kalbitor is also the only therapy that is not purified from human plasma that has been approved to treat this patient group. The FDA approval of this label expansion for Kalbitor is supported by the results from two previously completed Phase 3 placebo-controlled clinical studies, known as EDEMA3® and EDEMA4® as well as the results of study DX-88/19, which was ongoing at the time of the o ... Read more

Related support groups: Hereditary Angioedema, Kalbitor, Ecallantide

CSL Behring Receives FDA Approval of Expanded Label on Berinert for Self-administration and Treatment of Acute Laryngeal Attacks of Hereditary Angioedema

Posted 4 Jan 2012 by Drugs.com

Patients with rare, sometimes life-threatening condition can now treat themselves at home at the first sign of acute facial, abdominal or laryngeal swelling attacks 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 t ... Read more

Related support groups: Hereditary Angioedema, Berinert, C1 Inhibitor (Human)

FDA Approves Shire's Firazyr (icatibant injection) for Acute Attacks of Hereditary Angioedema (HAE)

Posted 25 Aug 2011 by Drugs.com

DUBLIN, Ireland and LEXINGTON, Massachusetts, August 25, 2011 – Shire plc, the global specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Firazyr (icatibant injection) for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. "Until now, HAE patients faced challenges gaining rapid access to acute treatment such as the need to travel to the physician's office or hospital," said Timothy Craig, Professor of Medicine & Pediatrics, Penn State Hershey Medical Center. "Firazyr is a treatment with demonstrated efficacy that can be carried and stored at room temperature and self-injected by the patient. Firazyr addresses this important unmet need by providing HAE patients with fast access to acute treatment." HAE is a debilitating rare genetic disease characterized by ... Read more

Related support groups: Hereditary Angioedema

Firazyr Approved for Rare Swelling Disease

Posted 25 Aug 2011 by Drugs.com

THURSDAY, Aug. 25 – Firazyr (icatibant) has been approved by the U.S. Food and Drug Administration to treat acute (severe) attacks of hereditary angiodema (HAE) in adults. The rare genetic condition is caused by low amounts of a protein called C1 inhibitor. Fewer than 30,000 people in the United States have the condition, the agency said in a news release. It causes potential symptoms including rapid swelling of the hands, feet, limbs, face, intestines and voice pipe. Airway swelling puts victims at risk of suffocation, the FDA said. The drug's safety and effectiveness were evaluated in clinical testing involving 225 patients. Symptom relief took an average of two hours among people who took the drug, versus almost 20 hours among those who took a placebo, the agency said. Common side effects included injection site reactions, fever, an increase in liver enzymes, dizziness and rash. Two ... Read more

Related support groups: Hereditary Angioedema

New Drug Studied for Hard-to-Treat Vascular Condition

Posted 5 Aug 2010 by Drugs.com

WEDNESDAY, Aug. 4 – A drug called icatibant is effective in treating acute attacks of a condition that causes potentially life-threatening swelling in the throat and other parts of the body, new research shows. People with hereditary angioedema (HAE) suffer recurrent episodes of swelling caused by fluid leaking from blood vessels. It can occur in a number of areas, including the face, extremities, gastrointestinal tract or the throat and larynx, where it can cause dangerous blockage of the airway, researchers explained in a news release from Massachusetts General Hospital in Boston, where one of two recent trials of the drug was based. The other trial was in Europe. The condition is caused by low levels or poor function of a protein called C1 esterase inhibitor. The new drug, icatibant, blocks the receptor for a protein called bradykinin, which is thought to play a role in many HAE ... Read more

Related support groups: Hereditary Angioedema

Dyax Announces FDA Approval of Kalbitor (ecallantide) for the Treatment of Acute Attacks of Hereditary Angioedema in Patients 16 Years of Age and Older

Posted 2 Dec 2009 by Drugs.com

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dec 1, 2009 - Dyax Corp. 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. HAE is a rare, genetic disorder characterized by severe, debilitating and often painful swelling, which can occur in the abdomen, face, hands, feet and airway. Kalbitor, a potent, selective and reversible plasma kallikrein inhibitor discovered and developed by Dyax, is the first subcutaneous HAE treatment approved in the U.S. As part of product approval, Dyax has, together with the FDA, established a Risk Evaluation and Mitigation Strategy (REMS) program to communicate the risk of anaphylaxis and the importance of distinguishing between a hypersensitivity reaction and HAE attack symptoms. "The approval of Kalbitor ... Read more

Related support groups: Hereditary Angioedema

CSL Behring Announces FDA Approval of Berinert, First and Only Therapy Approved for the Treatment of Acute Abdominal and Facial Attacks of Hereditary Angioedema in U.S.

Posted 2 Dec 2009 by Drugs.com

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 ... Read more

Related support groups: Hereditary Angioedema

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Related Condition Support Groups

Angioedema

Related Drug Support Groups

Berinert, Kalbitor, c1 inhibitor (human), Cinryze, Firazyr, ecallantide, icatibant