Eligible patients living with rare debilitating genetic disorder are one step closer to having access to first-of-its-kind treatment option

• Takeda Canada Inc. is pleased to announce it has completed the Letter of Intent with the pan Canadian Pharmaceutical Alliance (pCPA) for TAKHZYRO^® (lanadelumab injection) to treat people living with hereditary angioedema (HAE)
• HAE is a rare genetic disorder that can result in unpredictable and potentially life-threatening, recurring attacks of debilitating and painful swelling in various parts of the body^1,2,3

TORONTO, Nov. 5, 2020 /CNW/ - Takeda Canada Inc. is pleased to announce that it has completed its negotiations with the pan Canadian Pharmaceutical Alliance (pCPA) with a Letter of Intent (LOI) regarding TAKHZYRO^® (lanadelumab injection) for routine prevention of hereditary angioedema (HAE) attacks in adolescents and adults (12 years of age and older).⁴

This is an important step to ensure equitable and timely access to TAKHZYRO^® for eligible patients across Canada. The signed LOI allows Takeda Canada to work with participating jurisdictions to implement public funding of TAKHZYRO^® for eligible HAE patients.

"HAE is a rare, genetic disease that can result in recurring attacks of swelling in various parts of the body, which can be debilitating, painful, and in some cases, life threatening," said Stephen D Betschel, HBSc, MD, FRCPC, and Chair of The Canadian Hereditary Angioedema Network (CHAEN). "TAKHZYRO^® has the potential to transform care for patients and as a physician who treats this chronic condition, I hope to see rapid access for patients who can benefit from this important treatment option."

Following a priority review, Health Canada authorized TAKHZYRO^® for routine prevention of attacks of HAE in adolescents and adults (12 years of age and older) in September 2018. In addition, Health Canada issued the Notice of Compliance (NOC) for the new presentation (300 mg/ 2 mL Prefilled Syringe) in September 2020. In November 2019, TAKHZYRO^® received a positive recommendation from CADTH's Canadian Drug Expert Committee for the routine prevention of HAE attacks.

"Patients constantly live in fear of their next attack. They avoid social situations, even just going out in public, and this has a significant impact on their quality of life," said Jacquie Badiou, President, Hereditary Angioedema (HAE) Canada. "The HAE community is thrilled with this positive step forward, because having access to a treatment option that can prevent attacks would be life-changing." 

As one of the fastest-growing pharmaceutical companies in Canada, Takeda Canada is committed to delivering better health for Canadians through leading innovations in medicine.

"At Takeda, we always strive to do more for patients, and we are pleased to reach this important milestone for TAKHZYRO^®," said Gamze Yüceland, General Manager, Takeda Canada Inc. "With the Letter of Intent in place, this lays the path forward for funding discussions with each of the participating jurisdictions, and we look forward to working with our partners to bring this important therapy to Canadians living with HAE as soon as possible."

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).⁴

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 necessary.⁴

It is not known if TAKHZYRO^® is safe and effective in children under 12 years of age.⁴ Consult the current TAKHZYRO® Canadian product monograph for contraindications, warnings, precautions, adverse reactions, interactions, dosing, and conditions of clinical use.⁴

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. TAKHZYRO^® is marketed in Canada under Shire Pharma Canada ULC, which was acquired by Takeda in January 2019.

About Hereditary Angioedema (HAE)
HAE is a rare, genetic disorder estimated to affect about 1 in 10,000 to 1 in 50,000 people worldwide.^2,5 The condition results in recurring attacks of edema (swelling) in various parts of the body that can be debilitating and painful.^1,2,3,5 Laryngeal attacks that obstruct the airways are potentially life-threatening due to the risk of asphyxiation.^1,2,3 Aside from the burden of the disease itself, patients can suffer anxiety, fatigue and depression between attacks.⁶

About Takeda Canada Inc.
Takeda Canada Inc. is the Canadian marketing and sales organization of Takeda Pharmaceutical Company Limited, headquartered in Japan. Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Gastroenterology (GI), Rare Diseases and Neuroscience. 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. 

Additional information about Takeda Canada is available at www.takeda.com/en-ca  

References
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1	Banerji A. The burden of illness in patients with hereditary angioedema. Ann Allergy Asthma Immunol. 2013;111(5):329-336.
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	Zuraw BL. Hereditary angioedema. N Engl J Med. 2008;359(10):1027-1036.
4	TAKHZYRO® (lanadelumab) Summary of Product Characteristics (SmPC); July 24, 2020
5	Longhurst HJ, Bork K. Hereditary angioedema: causes, manifestations, and treatment. Br J Hosp Med. 2006;67(12):654-657.
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 Contact: Amanda Jacobs, [email protected], [phone]

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