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Feb 08, 2012

U.S. Senate Declares May 16, 2012 as Hereditary Angioedema Awareness Day

Resolution recognizes need for more education, research into rare, serious genetic disorder.

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By U.S. Hereditary Angioedema Association (HAEA)
U.S. Hereditary Angioedema Association (HAEA)
Last modified: 2012-02-06T17:08:10Z
Published: Monday, Feb. 6, 2012 – 9:07 am
Copyright 2012 . All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
HONOLULU, Feb. 6, 2012 — /PRNewswire/ — The U.S. Hereditary Angioedema Association (HAEA) announced today that the United States Senate has unanimously passed a resolution (S. Res. 286) recognizing May 16, 2012, as Hereditary Angioedema (HAE) Awareness Day. The resolution, offered by Senator Daniel Inouye (D-Hawaii) and Senator Saxby Chambliss (R-Georgia), is the result of a year-long political advocacy effort to generate recognition of the significant need for increased professional education regarding HAE, a rare and potentially fatal genetic disorder, and to highlight the need for further research aimed at improving diagnosis and treatment options for patients.

“This first annual HAE Awareness Day will put a spotlight on HAE, its symptoms, and the impact this challenging disorder has on patients and their families,” said Janet Long, Executive Vice President of the HAEA. “We hope this national recognition will broaden awareness of HAE and prompt anyone who suffers from repeated bouts of swelling to seek appropriate diagnosis and treatment.”

HAE involves episodes of edema, or swelling, in the face, feet, hands, throat, and abdomen. For most patients, HAE is caused by a defect or deficiency of the blood protein C1-esterase inhibitor. HAE experts estimate that this form of HAE occurs in 1 in 10,000 to 1 in 50,000 people. Swelling symptoms identical to HAE have been identified in families that have normal C1-esterase inhibitor levels. Commonly referred to as HAE III, scientists are studying the possible causes for swelling in this patient group. HAE attacks that involve the face or throat can result in airway closure, asphyxiation and, if untreated, death. Because the disease is very rare, it is not uncommon for patients to remain undiagnosed for many years, receive inappropriate diagnoses or undergo unnecessary exploratory surgery. Medications approved by the Food and Drug Administration (FDA) for treating the symptoms of HAE are now available in the U.S.

The goals of HAE Awareness Day are to:

Increase awareness of HAE among the general public and medical community
Support better care and an earlier and more accurate diagnosis for HAE patients
Raise funds for further national and international initiatives
Enhance the understanding that HAE patients can lead a healthy life
The day will help launch the first biannual HAE Global Conference to be held at the Scandic Hotel Sydhavnen in Copenhagen, Denmark. Findings from the conference will be the impetus for additional HAE research.

Funding and support of the HAEA’s public policy program, which encouraged the Senate to acknowledge the need for increased awareness and research, were provided by CSL Behring through the company’s Local Empowerment for Advocacy Development (LEAD) program.

For more information about HAE Awareness Day, please visit www.haeday.org.

About the U.S. Hereditary Angioedema Association (HAEA)Founded and staffed by HAE patients and HAE patient caregivers, the HAEA is a non-profit patient advocacy organization dedicated to serving persons with angioedema resulting from C1-Inhibitor deficiency. The Association provides HAE patients and their families with a support network and a wide range of services including physician referrals and individualized patient support. The HAEA’s goal is to increase awareness of Hereditary Angioedema by providing patients and physicians with authoritative and readily accessible information. The HAEA is committed to advancing and conducting clinical research designed to improve the lives of HAE patients and ultimately find a cure. To learn more about the HAEA or join the Association, visit www.HAEA.org, email info@haea.org or call 866-798-5598 begin_of_the_skype_highlighting 866-798-5598 end_of_the_skype_highlighting.

Contact:Laura de ZutterMCS Healthcare Public Relations on behalf of the HAE Association800-477-9626laurad@mcspr.com

SOURCE U.S. Hereditary Angioedema Association (HAEA)

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Feb 08, 2012

ViroPharma Provides Update on Industrial Scale Supplement for Cinryze® (C1 Esterase Inhibitor [Human])

EXTON, Pa., Feb. 7, 2012 /PRNewswire/ — ViroPharma Incorporated (Nasdaq: VPHM) today announced the U.S Food and Drug Administration (FDA) issued a complete response letter regarding Cinryze® (C1 Esterase Inhibitor [Human]) industrial scale manufacturing expansion activities. Specifically, the FDA has three comments related to a portion of the cleaning validation for industrial scale manufacturing, of which only one requires additional unplanned activity. The company expects that the additional activity required to address this comment can be completed in a short time frame. The FDA also noted that it has not yet completed the review of ViroPharma’s January 2012 updated responses to observations specific to the September 2011 inspection of the Amsterdam facility. There are no remaining technical comments posed by FDA in the complete response letter. The company intends to provide an update to shareholders on specific timing of resubmission and expected action dates during the 2011 Financial Results conference call to be held later this month.

“We and our partner Sanquin will begin working immediately to respond to the FDA as expeditiously as possible,” said Robert Pietrusko, Pharm.D., ViroPharma’s vice president, global regulatory affairs and quality. “We remain confident in our ability to gain approval of the industrial scale manufacturing of Cinryze in 2012.”

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Feb 01, 2012

US HAEA Announcement: HAE Day Congressional Resolution Passes

Exciting news! The US HAEA is proud to announce that, following a year-long political advocacy effort, a Congressional Resolution (S. Res. 286) has been unanimously passed in the US Senate, marking May 16, 2012 as Hereditary Angioedema Awareness Day in the United States.

This is an amazing accomplishment for a rare disease patient community and we hope you will proudly spread the word to your family and friends.

Congratulations to all of our HAEA friends on this great achievement!

Warm regards,

Tony Castaldo, President

http://www.gpo.gov/fdsys/pkg/CREC-2012-01-31/pdf/CREC-2012-01-31-pt1-PgS222-2.pdf#page=1

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Jan 03, 2012

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

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 treatment can increase the severity of that attack. This can lead to a patient needing to be hospitalized,” said Dr. Bruce Zuraw, Professor of Medicine-in-Residence, University of California, San Diego, School of Medicine. “However, if a patient self-administers therapy as soon as symptoms begin to appear, these problems can usually be averted. Clearly, this label expansion for Berinert is an extremely important advance in the on-demand treatment of attacks of HAE. Home-based self-administration provides HAE patients with a great opportunity to improve their lives.”

Intervention with Berinert at the onset of an abdominal or facial HAE attack has been shown to provide significantly faster relief to a patient (median onset of relief of 48 minutes in clinical trials, versus more than four hours in placebo group). In a non-placebo extension study, the use of Berinert to treat laryngeal attacks provided a median onset of relief of 15 minutes, which is significant due to the potentially life-threatening nature of these attacks.

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Dec 06, 2011

ViroPharma And Halozyme Therapeutics Announce Positive Data From Initial Phase 2 Assessment Of Subcutaneous Cinryze® (C1 Esterase Inhibitor [human]) With Hyaluronidase (rHuPH20)

EXTON, Pa., Dec. 6, 2011 /PRNewswire/ — ViroPharma Incorporated (Nasdaq: VPHM) and Halozyme Therapeutics (Nasdaq: HALO) today announced positive top line data from ViroPharma’s open-label, multiple dose Phase 2 clinical trial designed to evaluate the safety, pharmacokinetics and pharmacodynamics of subcutaneous administration of Cinryze® (C1 esterase inhibitor [human)] in combination with Halozyme’s Enhanze™ technology, a proprietary drug delivery platform using Halozyme’s recombinant human hyaluronidase enzyme (rHuPH20), in subjects with hereditary angioedema (HAE), a rare, debilitating and potentially fatal genetic disease.

In this study, the addition of rHuPH20 led to higher maximum levels and greater systemic exposure of functional and antigenic C1 inhibitor (C1 INH) for both Cinryze doses evaluated (1000 and 2000 units) as compared to subcutaneous administration of Cinryze alone. In addition, administration of Cinryze with rHuPH20 resulted in mean functional C1 INH levels that are clinically relevant and potentially associated with protection against HAE attacks. The most commonly reported adverse events are mild local injection site reactions such as erythema and pain.

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