“My team and I took part in the clinical trials that led to the approval of TAKHZYRO®, and we are pleased that the medicine is now available for the treatment of patients with hereditary angioedema,” said Dr. Jacques Hebert, Immunology and Allergy Clinic, CHUL. “The treatment philosophy has evolved over the years. About ten years ago, prophylaxis was used to reduce the morbidity and mortality related to this clinical condition. With modern medicine that is proven to be safe and effective, such as TAKHZYRO®, prophylaxis aims to help patients lead normal lives without recurrence or attacks.”

“Patients with hereditary angioedema have long been limited to acute attack treatments. Having access to safe and effective preventive treatment is a major advancement for our patients,” said Dr. Rémi Gagnon, Head of the Department of Allergy and Immunology, CHU de Québec. “Many of our Quebec patients have played a pivotal role in this treatment’s development by participating in the research protocols of the Clinique spécialisé en allergie de la capitale. Making Lanadelumab available improves patient care by giving them a better quality of life.”

“Patients with HAE constantly live in fear of their next attack, often disrupting day to day activities such as work, family and social interactions, and significantly impacting their quality of life,” said Charles St. Pierre, President, Hereditary Angioedema Quebec/Angio-Oedeme Hereditaire du Quebec. “The HAE community is delighted that TAKHZYRO® is now available for patients living in Quebec because having access to a treatment option that can prevent attacks would be life-changing for those living with HAE.”

The awarding of the Héma-Québec tender is the most recent milestone for TAKHZYRO® since receiving Health Canada authorization for routine prevention of attacks of HAE in adolescents and adults (12 years of age and older) in September 20181. Since then, Health Canada has issued the Notice of Compliance (NOC) for a Prefilled Syringe (300 mg/ 2 mL) presentation in September 2020, as well as receiving a positive recommendation from CADTH’s Canadian Drug Expert Committee for the routine prevention of HAE attacks in November 2019, and from the Institut national d’excellence en santé et en services sociaux (INESSS) in August 2020.

“We’re extremely proud of this agreement with Héma-Québec and what it represents for HAE patients,” said Rute Fernandes, General Manager, Takeda Canada. “This collaboration is an
important step to ensure patients with type I and type II HAE have to access TAKHZYRO® and the improvement of care that is now available to them. This is an example of how our commitment to meeting the needs of patients living with a rare disease has resulted in greater access for patients across the country.”

About TAKHZYRO^® (lanadelumab injection)

TAKHZYRO® is a fully human monoclonal antibody indicated for routine prevention of attacks of hereditary angioedema (HAE) in adolescents and adults (12 years of age and older)¹.

TAKHZYRO® is not intended for acute treatment of HAE attacks. Patients and caregivers should continue to be prepared to treat attacks with acute HAE treatments when necessary¹.

It is not known if TAKHZYRO® is safe and effective in children under 12 years of age1. Consult the current TAKHZYRO® Canadian product monograph for contraindications, warnings, precautions, adverse reactions, interactions, dosing, and conditions of clinical use¹.

TAKHZYRO® is approved in the U.S. (August 2018), E.U. (November 2018), Australia (January 2019) and Switzerland (June 2019) and additional regulatory submissions are ongoing worldwide.

About Hereditary Angioedema (HAE)

HAE is a rare, genetic disorder estimated to affect about 1 in 10,000 to 1 in 50,000 people worldwide²³. The condition results in recurring attacks of edema (swelling) in various parts of the body that can be debilitating and painful⁴²⁵³. Laryngeal attacks that obstruct the airways are potentially life-threatening due to the risk of asphyxiation⁴²⁵. Aside from the burden of the disease itself, patients can suffer anxiety, fatigue and depression between attacks⁶.

About Takeda Canada Inc.

Takeda Canada Inc. is the Canadian organization of Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK), a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discovering and delivering life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions. For more information, visit: takeda.com/en-ca

Media Contacts:

Amanda Jacobs
amanda.jacobs@takeda.com
+1 647-798-2231
###

References

1 TAKHZYRO Product Monograph; March 2021
2 Cicardi M, Bork K, Caballero T, et al, on behalf of HAWK (Hereditary Angioedema International Working Group). Evidence-based recommendations for the therapeutic management of angioedema owing to hereditary C1 inhibitor deficiency: consensus report of an International Working Group. Allergy. 2012;67(2):147-157.
3 Longhurst HJ, Bork K. Hereditary angioedema: causes, manifestations, and treatment. Br J Hosp Med. 2006;67(12):654-657.
4 Banerji A. The burden of illness in patients with hereditary angioedema. Ann Allergy Asthma Immunol. 2013;111(5):329-336.
5 Zuraw BL. Hereditary angioedema. N Engl J Med. 2008;359(10):1027-1036.
6 Fouche AS, Saunders EFH, Craig T. Depression and anxiety in patients with hereditary angioedema. Ann Allergy Asthma Immunol. 2014;112(4):371–375.

The post Héma-Québec Awards Takeda Canada Two-Year Tender for Hereditary Angioedema treatment TAKHZYRO^® appeared first on Angio-oedème Héréditaire du Québec.

For Immediate Release

HAEGARDA^® is now available in the province of Québec for the routine prevention of Hereditary Angioedema (HAE)                         attacks in adolescent and adult patients

OTTAWA, Canada, 5 February 2020. CSL Behring Canada announced that HAEGARDA^® (C1 Esterase Inhibitor Subcutaneous [Human]), is now available in the province of Québec. HAEGARDA is a subcutaneous C1 esterase inhibitor (C1-INH) therapy indicated for routine prophylaxis to prevent hereditary angioedema (HAE) attacks in adolescent and adult patients¹.

“Hereditary angioedema (HAE) is a rare hereditary disease that manifests itself as unpredictable and often severe attacks of edema and/or abdominal pain…” said Dr. Jacques Hebert, MD, FRCPC, Director at the Centre de Recherche Appliquée en Allergies de Québec, and Research Associate at the Laval University, Québec “…Preventive therapy was based on intravenous administration replacement therapy of the defective serum protein. A key limitation was the IV route of administration. HAEGARDA^® is intended for self-administration by subcutaneous injection only.”

HAE is caused by deficient or dysfunctional C1-INH, a protein in the blood that helps to control inflammation, and causes the edema attacks associated with the disease. Depending on the severity of the disease, patients could experience several debilitating attacks each month. Laryngeal attacks, which are experienced by more than half of all HAE patients during their lifetime block the airway and can be fatal – with mortality rates as high as 33 percent in untreated patients^2,3,4.

“The availability of a new treatment option to help health care professionals and patients prevent HAE attacks is an important milestone and great news for the HAE patient community.” Said Charles St-Pierre, President of the AOHQ patient group.

CSL Behring Canada is also committed to help patients get access to training for the administration of HAEGARDA^® via CSL Behring PLUS+ program that offers a wide array of services, and educational materials. Patients can ask their Healthcare professionals to enroll them in the program at any time.

For more information and a complete risk/benefit profile, please contact Customer Service at 1-866-773-7721 ext. 2386 or refer to the Product Monograph available on CSL Behring website at www.cslbehring.ca.

About Hereditary Angioedema

HAE is a rare genetic disorder caused by a deficiency of C1-INH. It is inherited in an autosomal dominant manner. Symptoms of HAE include episodes of edema, or swelling, in the hands, the feet, the face, the abdomen, and/or the larynx. Patients who have abdominal attacks of HAE can experience episodes of extreme pain, diarrhea, nausea and vomiting caused by swelling of the intestinal wall. HAE attacks that involve the face or throat can result in upper airway closure, asphyxiation and, if untreated, death. Diagnosis of HAE requires a blood test to confirm low or abnormal levels of C1-INH.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients’ needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat coagulation disorders, primary immune deficiencies, hereditary angioedema, inherited respiratory disease, and neurological disorders. The company’s products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic disease of the newborn.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. The parent company, CSL Limited (ASX:CSL), headquartered in Melbourne, Australia, employs nearly 20,000 people, delivering its life-saving therapies to people in more than 60 countries. For more information visit www.cslbehring.com and follow us on www.Twitter.com/CSLBehring.

Media Contact
Dana Lynch
Office: +1 (610) 878-4545
Email:  dana.lynch@cslbehring.com
_____________________________________________________

1. HAEGARDA^® Product Monograph. CSL Behring Canada, Inc. August 13, 2019
2. Bork K, et al. Clinical studies of sudden upper airway obstruction in patients with hereditary angioedema due to C1 esterase inhibitor deficiency. Ach Intern Med. 2003;163:1229-35.
3. Bork K, et al. Efficacy of different medical therapies for the treatment of acute laryngeal attacks of hereditary angioedema due to C1-esterase inhibitor deficiency. J Emerg Med. 2016;50(4):567-80.
4. Bork K, et al. Fatal laryngeal attacks and mortality in hereditary angioedema due to C1-INH deficiency. J Allergy Clin Immunol. 2012 Sep;130(3):692-7

The post HAEGARDA® is now available in the province of Québec appeared first on Angio-oedème Héréditaire du Québec.

Will be held a conference day to inform about hereditary angioedema

The activity is open to anyone interested or interested in the subject (patients, caregivers, professionals and health managers, representatives of the pharmaceutical industry, etc.)

The morning will be dedicated to scientific conferences while a workshop will be offered to patients and their loved ones in the afternoon. The medical staff will be invited to an accredited training.

Take advantage of this day at no cost to get information from our internationally renowned professionals. A dinner and a cocktail reception will be served. As an association, we will hold our annual general meeting that same day. Limited seating. On registration only. Deadline: September 22, 2018.

SIMULTANEOUS TRANSLATION OFFERED

Register for the event here

The post Educational Day 2018 appeared first on Angio-oedème Héréditaire du Québec.

For the occasion, two pairs of tickets for the Desjardins section of the Montreal Canadiens at Bell Center (unlimited food and soft drinks) will be drawn among the listeners of the Jeff Fillion show between 11:30 am and 2:00 pm. We warmly invite you to visit www.aohq.ca, and share on your social networks.

AOHQuebec is always looking for solutions to improve the quality of life of its members, by providing them with up-to-date information and by sharing new medical advances related to hereditary angioedema.

The AOHQuebec will be very happy to read your comments and to exchange with you!

Charles St-Pierre

President

Hereditary Angioedema of Quebec (AOHQ)

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