Héma-Québec Awards Takeda Canada Two-Year Tender for Hereditary Angioedema Treatment TAKHZYRO®

TORONTO, April 28, 2022 /CNW/ - Takeda Canada Inc. is pleased to announce that Héma-Québec has awarded a two-year tender for TAKHZYRO^® (lanadelumab injection) as the sole option for prophylaxis subcutaneous (SC) treatment for type I/II hereditary angioedema (HAE) patients. The two-year term which begins April 1, 2022, includes the option for Héma-Québec to extend the tender for an additional two years.

"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, Head, 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 access to 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 

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.

SOURCE Takeda Canada

Media Contacts: Amanda Jacobs, [email protected], [phone]