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Hereditary Angioedema News

Related terms: Quincke's disease, HAE

FDA Approves Haegarda - First Subcutaneous C1 Esterase Inhibitor for Hereditary Angioedema

Posted 26 Jun 2017 by Drugs.com

June 22, 2017 – The U.S. Food and Drug Administration today approved Haegarda, the first C1 Esterase Inhibitor (Human) for subcutaneous (under the skin) administration to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients. The subcutaneous route of administration allows for easier at-home self-injection by the patient or caregiver, once proper training is received. HAE, ...

FDA Approves Ruconest for Hereditary Angioedema

Posted 18 Jul 2014 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 ...

Ruconest Approved for Rare Genetic Disease

Posted 18 Jul 2014 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 ...

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 ...

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 p ...

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 ...

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 ...

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, ...

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 ...

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 ...

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Related Condition Support Groups

Angioedema

Related Drug Support Groups

stanozolol, Winstrol, Berinert, Kalbitor, c1 inhibitor (human), Cinryze, ecallantide, icatibant, conestat alfa, Firazyr, Ruconest, Haegarda