PrBIMZELX® (bimekizumab injection) approved in Canada for treatment of moderate to severe hidradenitis suppurativa (HS)

• The approval is based on clinically significant results from UCB's two pivotal Phase III trials demonstrating significant clinical improvements in patients' disease activity globally compared to placebo at Week 16 with Hurley Stage II/III HS and inadequate response to antibiotics when treated with ^PrBIMZELX^® (bimekizumab injection).

OAKVILLE, ON, Jan. 13, 2026 /CNW/ - UCB Canada Inc. is pleased to announce Health Canada has granted a Notice of Compliance (NOC) for ^PrBIMZELX^® (bimekizumab injection) indicated for the treatment of adult patients with moderate to severe hidradenitis suppurativa (HS) with an inadequate response to conventional systemic therapy.

HS is a debilitating, chronic inflammatory skin disease characterized by recurrent and painful subcutaneous nodules, abscesses, and draining sinus tracts.¹

"New treatment options can help address a critical unmet need in hidradenitis suppurativa, empowering patients and clinicians with greater choice and hope for improved outcomes," says Dr. Raed Alhusayen, MD, Dermatologist and HS specialist, Toronto, Canada.

"At UCB Canada, we strive to make a material difference in the lives of patients with immunological conditions like HS. We were proud to see this purpose move forward through the findings of BE HEARD I and II, which were partially conducted in Canada, and we are thankful to all the participants within those studies across the globe," says Andrea Loewendorf, Head, Immunology Business Unit, UCB Canada. "We are excited about the potential for positive impact this approval for ^PrBIMZELX^® (bimekizumab injection) could have on the quality of life of Canadians impacted by HS."

"For years, people living with hidradenitis suppurativa have carried not just the physical pain, but also the emotional weight of being misunderstood," says Latoya Palmer, Founder of the Hidradenitis & Me Support Group. "This approval brings something powerful: hope, dignity, and a sense of finally being seen. It reminds us that when patients, healthcare providers, and industry work together with empathy and purpose, real change becomes possible."

This is the fifth indication for ^PrBIMZELX^® (bimekizumab injection) in Canada, already having indications in chronic conditions in dermatology and rheumatology.^{2  Pr}BIMZELX^® (bimekizumab injection) demonstrated clinically meaningful improvements in disease activity compared to placebo at Week 16, in patients with moderate to severe hidradenitis suppurativa.² The approval was granted based on the results of two Phase III trials, BE HEARD I and BE HEARD II, which evaluated over 1,000 adult patients globally.

About HS

HS is a chronic, recurring, painful, and debilitating inflammatory skin disease.^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 the BE HEARD Trials:

BE HEARD I and II were randomized, double-blind, placebo-controlled Phase III trials designed to evaluate the efficacy and safety of bimekizumab in adult patients with moderate to severe HS. The primary endpoint in both trials was the proportion of patients achieving HiSCR50 at Week 16, defined as at least a 50% reduction in total abscess and inflammatory nodule count with no increase in abscess or draining tunnel count relative to baseline. Results for HiSCR75 and HiSCR90 were also observed. Treatment with ^PrBIMZELX^® (bimekizumab injection) resulted in statistically significant improvements in HiSCR50 response compared to placebo at Week 16. Clinical responses were sustained through Week 48 in both studies. The trials enrolled 1,014 patients globally.² Participants had moderate to severe HS (Hurley Stage II or III) for at least six months, with a minimum of five inflammatory lesions and a history of inadequate response to systemic antibiotics.

In clinical trials, treatment with ^PrBIMZELX^® (bimekizumab injection) was generally well tolerated. The most common adverse events included diarrhea, fatigue, injection site reactions, upper respiratory tract infections, oral candidiasis, headache and skin irritation. The majority were non-serious and mild to moderate in nature. In the placebo-controlled period (up to Week 16) of the BE HEARD I and II trials, 33.0% of patients receiving ^PrBIMZELX^® (bimekizumab injection) reported infections, compared to 20.5% with placebo. Serious infections were rare, occurring in only 0.1% of ^PrBIMZELX^® (bimekizumab injection) -treated patients and none in the placebo group. Over the entire treatment period of Phase III studies in HS, infections were reported in 68.0% of patients treated with ^PrBIMZELX^® (bimekizumab injection). More information about ^PrBIMZELX^® (bimekizumab injection) can be found by accessing the Product Monograph at https://www.ucb-canada.ca/en/bimzelx.

About ^PrBIMZELX^® (Bimekizumab Injection):

This is the fifth indication for ^PrBIMZELX^® (bimekizumab injection) in Canada. ^PrBIMZELX^® (bimekizumab injection) 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 therapy²; and for the treatment of adult patients with moderate to severe hidradenitis suppurativa (HS) with an inadequate response to conventional systemic therapy (approved in 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.^{2,7,8,9 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.ca/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 20th 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

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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. BIMZELX^® (bimekizumab injection), Product Monograph, UCB Canada Inc., December 2025.

3. Jemec 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. Merola JF, Landewé R, McInnes IB, et al. Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α inhibitors: a randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE). Lancet. 2023;401(10370):38–48.

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. https://arthritis.ca/about-arthritis/arthritis-types-(a-z)/types/psoriatic-arthritis/psoriatic-arthritis-symptoms-and-diagnosis. Accessed March 2024.

9. About UCB: https://www.ucbcanada.com/en/about-ucb

SOURCE UCB Canada Inc.

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