Public Access to ANDEMBRY® (garadacimab) Expands Across Canada for the Prevention of Hereditary Angioedema (HAE) Attacks

• Quebec became the first Canadian province to publicly reimburse ANDEMBRY^®,¹ followed by Alberta effective September 1, 2026, expanding provincial public access for eligible Canadians living with HAE.²
• ANDEMBRY^® is also covered through federal programs, including the Non-Insured Health Benefits (NIHB) Program and Veterans Affairs Canada (VAC), further broadening access for eligible patients.
• Hereditary angioedema (HAE) is a rare genetic condition characterized by recurrent and unpredictable swelling attacks that can cause severe abdominal pain and a potentially life-threatening airway condition.³
• ANDEMBRY^® has been nominated for the 2026 Prix Galien USA Award in the Best Biotechnology Product category, recognizing innovators in life sciences.⁴

OTTAWA, ON, Sept. 22, 2026 /CNW/ -- CSL Canada announced today that public access to ANDEMBRY^® (garadacimab) is expanding in Canada, with reimbursement now available for eligible patients in Quebec and Alberta, as well as through the federal Non-Insured Health Benefits (NIHB) Program and Veterans Affairs Canada (VAC).

ANDEMBRY^® is the first and only once-monthly prophylactic treatment that targets activated factor XII (FXIIa) for the routine prevention of hereditary angioedema (HAE) attacks.⁵ The expanded public access represents an important milestone for eligible Canadians living with HAE and their families, providing access to an additional treatment option for this rare and potentially life-threatening swelling.³

Quebec became the first province in Canada to publicly reimburse ANDEMBRY^®. Effective July 30, 2026, ANDEMBRY^® is reimbursed by the Régie de l'assurance maladie du Québec (RAMQ) for eligible Quebec patients aged 12 years or older with Type I or Type II HAE who experience attacks that significantly interfere with their daily activities.¹

In Alberta, public coverage for ANDEMBRY^® is available effective September 1, 2026, through the Alberta Drug Benefit List (ADBL) via Special Authorization.² Coverage is also available to eligible patients through federal programs, including Veterans Affairs Canada (VAC) and the Non-Insured Health Benefits (NIHB) Program. 

"Living with hereditary angioedema can mean living with the constant uncertainty of not knowing when and where the next attack may occur," said Michelle Cooper, Hereditary Angioedema Canada. "For people living with HAE, having access to treatment options that can help prevent attacks can make a meaningful difference in quality of life. We welcome the expansion of provincial and federal coverage and the progress it represents for eligible patients and families across Canada." 

The expansion in public access comes as ANDEMBRY^® has also been nominated for the 2026 Prix Galien USA Award in the Best Biotechnology Product category. The Prix Galien Awards recognize achievements in life sciences innovation.⁴

"At CSL, we are committed to helping improve outcomes for Canadians living with hereditary angioedema," said Marie-Ève Jacques, General Manager, CSL Canada. "The expansion of public coverage for ANDEMBRY^® is encouraging progress toward making treatment options available to more eligible Canadians. We look forward to continuing to work with governments and healthcare partners to support access for people living with this rare disease."

About Hereditary Angioedema

Affecting approximately 1 in 50,000 Canadians, hereditary angioedema (HAE) is a rare, potentially life-threatening, genetic disease.¹ Clinically characterized by painful, recurrent, and unpredictable swelling attacks, the condition is often accompanied by severe abdominal pain, and airway restrictions that can be fatal.³ Attacks vary in frequency and severity, however, can often last for several days and can be disabling.³

About ANDEMBRY^®

ANDEMBRY^® is a once-monthly monoclonal antibody treatment that targets activated factor XII (FXIIa) and is administered as a 200 mg subcutaneous injection once monthly following the initial loading dose. In the Phase 3 VANGUARD study, ANDEMBRY^® demonstrated an 89% reduction in mean monthly HAE attacks versus placebo and a greater than 99% reduction in median monthly attacks versus placebo, with 62% of patients attack-free during the full six-month study period.⁶

Important Information for Canada

ANDEMBRY^® is indicated for routine prevention of attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. ANDEMBRY^® is not intended for acute treatment of HAE attacks.⁶

Consult the product monograph available here or by calling + 1-866-773-7721.

About CSL

CSL (ASX: CSL) (USOTC: CSLLY) is a leading global biopharma company with a dynamic portfolio of lifesaving medicines, including those that treat hemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency, dialysis and nephrology. Since our start in 1916, CSL has been driven by a promise to save lives using the latest technologies. Today, CSL – including three businesses, CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 29,000+ people. CSL's unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For inspiring stories about the promise of biotechnology, visit CSL.com/Vita.

For more information about CSL Canada, visit https://www.cslbehring.ca/.

References

1. Institut national d'excellence en santé et en services sociaux. Extract notice to the minister: Andembry (crises d'angiœdème héréditaire) (2025). Available from: https://www.inesss.qc.ca/en/themes/medicaments/drug-products-undergoing-evaluation-and-evaluated/extract-notice-to-the-minister/andembry-crises-dangioedeme-hereditaire-7285.html. Last Accessed: August 2026.
2. Alberta Blue Cross. Updates to the Alberta Drug Benefit List, effective September 1, 2026. Available from: https://idbl.ab.bluecross.ca/idbl/DBL/sep_dblupdate.pdf. Last Accessed:  September 2, 2026.
3. Jacqui Badiou et al. Real World Data Of Canadians Living With Hereditary Angioedema. Journal of Allergy and Clinical Immunology 2019; 143(2): 143AB172.
4. The Galien Foundation. The Galien Foundation Announces 2026 Prix Galien USA Nominees for "Best Biotechnology Product," "Best Pharmaceutical Product," and "Best Product for Rare/Orphan Diseases" (2026). Available from: https://www.prnewswire.com/news-releases/the-galien-foundation-announces-2026-prix-galien-usa-nominees-for-best-biotechnology-product-best-pharmaceutical-product-and-best-product-for-rareorphan-diseases-302848225.html. Last Accessed: September 2, 2026.
5. CSL Behring Canada Inc. Health Canada Has Authorized CSL's ANDEMBRY® (garadacimab) as Once-Monthly Treatment for Hereditary Angioedema (HAE) (2025). Available from:  https://www.cslbehring.ca/news/2025/health-canada-has-authorized-csl-andembry  Last Accessed: September 9, 2026.
6. CSL Behring Canada Inc. Product Monograph (2025). Available from: https://labeling.cslbehring.ca/PM/CA/Andembry/EN/Andembry-Product-Monograph.pdf. Last Accessed: August 2026.

Media Inquiries
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SOURCE CSL Canada