UCB Canada remains dedicated to helping patients and working collaboratively with CDA-AMC following draft recommendation for (Pr)BIMZELX® for hidradenitis suppurativa (HS)

Canadians living with HS at risk of inequitable access to newly approved therapy, falling behind Australia, France, Germany, Scotland and other jurisdictions.

OAKVILLE, ON, Jan. 21, 2026 /CNW/ - UCB Canada Inc. respectfully disagrees with the draft recommendation issued by the Canadian Drug Agency (CDA-AMC) regarding ^PrBIMZELX^® (bimekizumab injection) for the treatment of adults living with moderate to severe hidradenitis suppurativa (HS) who have not responded adequately to conventional systemic therapy. Canadian patients living with HS, clinicians, and UCB Canada urge the CDA-AMC to recognize the risk this recommendation poses to health equity and to the timely, appropriate care HS patients deserve.

"Having treated HS patients with bimekizumab in clinical trials, I have seen meaningful, sustained improvements in disease control that go beyond what we typically achieve with current HS therapies," noted Dr. Melina Gooderham, MSc, MD, FRCPC, SKiN Centre for Dermatology, Queen's University, and Probity Medical Research. "Seeing patients regain function, return to work, and truly get their lives back has been incredibly rewarding and highlights the real impact this treatment can have on quality of life."

This draft recommendation for public drug plans, excluding Quebec, advises not to reimburse ^PrBIMZELX^® for the treatment of HS. HS is a debilitating, chronic inflammatory skin disease characterized by recurrent and painful subcutaneous nodules, abscesses, and draining sinus tracts.¹ People living with moderate to severe HS experience significant impacts on their quality of life, physical and mental wellbeing, and capacity to complete everyday tasks as well as a high financial burden.² Treatment options remain limited, and many continue to experience ongoing disease activity despite existing therapies.

"As a patient living with hidradenitis suppurativa, knowing there are multiple treatments to help manage our HS gives us hope for better quality of life," said Latoya Palmer, Founder, Hidradenitis & Me Support Group.

UCB Canada is committed to working with the CDA-AMC to address all questions raised in the draft recommendation. The company remains confident in the meaningful value ^PrBIMZELX^® brings to people living with HS, based on its demonstrated clinical benefits and the unmet needs expressed by patients and clinicians.

"^PrBIMZELX^® represents a significant step forward for Canadians living with HS," said Rodrigo Reis, General Manager, UCB Canada. "We are deeply disappointed by this draft recommendation, which delays patient access to an important innovation already approved in 35 countries and markets. Backed by robust efficacy and safety data, ^PrBIMZELX^® not only offers new hope, but it also addresses a critical unmet need for the patients we serve."

On December 12, 2025, ^PrBIMZELX^® received Health Canada approval for the treatment of adults with moderate to severe HS with an inadequate response to conventional systemic therapy. This positive decision reflects the robust safety and efficacy data available, and UCB Canada will continue to support ^PrBIMZELX^® as a critical biologic therapy for patients, joining four existing ^PrBIMZELX^® indications approved by Health Canada, and funded by the majority of Canadian public payers.

"It is disappointing that access to bimekizumab for the treatment of hidradenitis suppurativa might be limited to patients who only have private insurance," said Dr. Mark Kirchhof, MD, PhD, FRCPC, Associate Professor – University of Ottawa, Head of Dermatology – University of Ottawa and The Ottawa Hospital. "Every patient with this disease should be able to access this efficacious medication."

"The Canadian Skin Patient Alliance is committed to advocating for the needs of people living with hidradenitis suppurativa and ensuring their voices are heard in decisions affecting access to care," said Dana Gies, Executive Director, Canadian Skin Patient Alliance (CSPA). "For people living with HS in Canada, recent recommendations further limit treatment options that are already fewer than those available in many other countries. It is critical patients and their healthcare providers have choices so care can be tailored to individual needs. Without adequate options, patients are left to manage unnecessary pain and suffering, which should not be the reality for those living with this serious, life-altering condition."

The draft recommendation for ^PrBIMZELX^® is open for feedback from eligible interested stakeholders until January 30, 2026, and may be submitted via the CDA-AMC website at https://www.cda-amc.ca/bimekizumab-2.

UCB Canada remains steadfast in its commitment to the HS community and will continue to work alongside patients, healthcare professionals, and system partners to support awareness, advance the understanding of HS, and explore pathways that enable timely and sustainable access to innovative therapies such as ^PrBIMZELX^®.

About HS:

HS is a chronic, recurring, painful, and debilitating inflammatory skin disease.^1,3,4 HS has been estimated to affect approximately one percent of the population, with women and people of colour disproportionately impacted.^1,5 Characterized by recurring nodules, abscesses, and pus-discharging openings in sensitive areas like the armpits, groin, and buttocks, HS can significantly reduce quality of life for those with the condition.⁴ Delayed diagnosis, stigma, and limited treatment options are all additional challenges faced by those living with HS.¹ 

About ^PrBIMZELX^® (bimekizumab injection):

HS is the fifth indication for ^PrBIMZELX^® (bimekizumab injection) in Canada. ^PrBIMZELX^® is indicated for the treatment of adults with moderate to severe plaque psoriasis (PsO) (as of February 14, 2022) who are candidates for systemic therapy or phototherapy; adults with active psoriatic arthritis (PsA) (as of February 23, 2024); adults with active ankylosing spondylitis (AS) (as of March 11, 2024) who have responded inadequately or are intolerant to conventional therapy; adults with active non-radiographic axial spondyloarthritis (nr-axSpA) (as of March 11, 2024) with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or MRI who have responded inadequately or are intolerant to conventional therapy⁶; and for the treatment of adult patients with moderate to severe hidradenitis suppurativa (HS) with an inadequate response to conventional systemic therapy (as of December 12, 2025).

^PrBIMZELX^® (bimekizumab injection) is a monoclonal antibody belonging to a group of medicines called interleukin (IL) inhibitors. Monoclonal antibodies are proteins that recognize and bind specifically to certain proteins in the body. This medicine works by reducing the activity of two cytokines called IL-17A and IL-17F, which are present at increased levels in diseases such as PsO, PsA, AS, nr-axSpA and HS.^{6,7,8,9 Pr}BIMZELX^® (bimekizumab injection) is already listed by the majority of Canadian public drug plans for moderate to severe PsO, PsA, and AS. Please consult the Product Monograph at https://www.ucbcanada.com/en/bimzelx for important information on:

• Relevant warnings and precautions regarding inflammatory bowel disease, serious hypersensitivity reactions, vaccinations, infections including tuberculosis, pregnant or nursing women, and women of childbearing potential.
• Conditions of clinical use, adverse reactions, drug interactions, and dosing instructions.

The Product Monograph is also available by calling 1-866-709-8444.

About UCB Canada Inc.:  

UCB Canada Inc. is the Canadian affiliate of UCB, a global biopharmaceutical leader dedicated to improving the lives of people with severe autoimmune and central nervous system diseases. Headquartered in Oakville, Ontario, UCB Canada employs over 100 people, located across the country. UCB Canada Inc. partners with healthcare professionals, research institutions, and patient organizations to advance access to innovative treatments and improve patient outcomes. In 2026, the company will celebrate its 20^th anniversary, marking two decades of dedication to Canadian patients, healthcare professionals, and communities. For more information, please visit https://www.ucbcanada.com/en/Home. 

About UCB:  

UCB is a global biopharmaceutical company focused on discovering and developing innovative medicines and solutions for severe diseases of the immune system or central nervous system. With more than 9,000 employees across nearly 40 countries,⁹ UCB is committed to making a meaningful difference in patients' lives worldwide. For more information, visit www.ucb.com.

References

	____________________________
	^1 Napolitano M, Megna M, Timoshchuk EA et al. Hidradenitis suppurativa: from pathogenesis to diagnosis and treatment. Clin Cosmet Investig Dermatol. 2017;10:105‑115. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5402905/.
	^2 Naik H B et al. Short-term efficacy of biologics in moderate-to-severe hidradenitis suppurativa: A systematic review and NMA. Journal of the European Academy of Dermatology & Venereology. 28 December 2025. https://doi.org/10.1111/jdv.70265
	^3Jemec GBE. Clinical practice. Hidradenitis suppurativa. N Engl J Med. 2012;366(2):158-164.
	^4 Sabat R, Jemec GBE, Matusiak L et al. Hidradenitis suppurativa. Nat Rev Dis Primers. 2020;6:18
	^5 Canadian Hidradenitis Suppurativa Foundation. Call to action: Improving the lives of people with hidradenitis suppurativa in Canada [Internet]. 2024 Jul [cited 2025 Jun 16]. Available from: https://hsfoundation.ca/wp-content/uploads/2024/07/Call-to-action-improving-the-lives-of-people-with-hidradenitis-suppurativa-in-Canada.pdf
	^6 BIMZELX^® (bimekizumab injection), Product Monograph, UCB Canada Inc., December 2025.
	^7 van der Heijde D, Deodhar A, Baraliakos X et al. Efficacy and safety of bimekizumab in axial spondyloarthritis: results of two parallel phase 3 randomized controlled trials. Ann Rheum Dis. Published Online First: January 2023. doi:10.1136/ard-2022-223595.
	^8 Arthritis Society Canada. Psoriatic Arthritis Symptoms and Diagnosis. Available from: https://arthritis.ca/about-arthritis/arthritis-types-(a-z)/types/psoriatic-arthritis/psoriatic-arthritis-symptoms-and-diagnosis. Accessed March 2024.
	^9 UCB. About UCB. Available from: https://www.ucb.com/about-ucb

SOURCE UCB Canada Inc.

For further information, please contact UCB: [email protected]