NEWS DETAIL

  • Source : PR Newswire
  • Date : 2022-02-17
  • Event type : Approved
  • Companies : UCB Pharma S.A.

Health Canada Approves BIMZELX (Bimekizumab) for the Treatment of Adults With Moderate to Severe Plaque Psoriasis

  • BIMZELX® (bimekizumab injection) is the first treatment for adults with moderate to severe plaque psoriasis that is designed to inhibit both IL-17A and IL-17F inhibitor to be approved by Health Canada.
  • Approval is supported by three Phase III trials, including significant Canadian participation, which evaluated the efficacy and safety of BIMZELX compared with placebo, ustekinumab and adalimumab.
  • BIMZELX is a testament to UCB's commitment to advancing science in immuno-dermatology, addressing unmet needs and improving patient outcomes.

OAKVILLE, ON, Feb. 17, 2022 /CNW/ - UCB Canada Inc. announced today that Health Canada has approved BIMZELX® (bimekizumab injection) for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.1 BIMZELX is the first IL-17A and IL-17F inhibitor to be approved in the Americas.

"The approval of BIMZELX in Canada is the first marketing authorization for this new psoriasis treatment in North America, and represents a pivotal moment for the dermatology community and UCB," said Lionel Houle, Head of Immunology, UCB Canada. "Our sights are set on innovative scientific solutions that can make a real difference in the lives of patients. We are incredibly proud to bring this new treatment option to people living with moderate to severe plaque psoriasis in Canada and believe that BIMZELX has the potential to raise expectations of what psoriasis treatment can deliver."

Psoriasis is a common chronic inflammatory skin condition usually characterized by red elevated patches and flaking silvery scales with symptoms ranging from mild to severe.2 Psoriasis affects one million Canadians and 125 million worldwide, with 90 per cent of patients having the most common form – plaque psoriasis.3

Psoriasis has a considerable psychological and quality of life impact, potentially affecting work, recreation, relationships, sexual functioning, family and social life.4 According to a Canadian patient survey completed by the Canadian Dermatology Association, psoriasis and related conditions impose a severe burden on the daily lives of Canadians with a history of moderate to severe psoriasis. More than one third of respondents (176 of 500) viewed their skin condition as a significant problem in their daily life, a perception that correlated with the extent of the disease.5

"Psoriasis places a tremendous burden on patients and their caregivers. Every day, I see firsthand the positive impact of effective treatment options," said Dr. Melinda Gooderham, board-certified Dermatologist, Medical Director at the SKiN Centre for Dermatology and Principal Investigator for the SKiN Research Centre in Peterborough, Ontario. "The introduction of bimekizumab could be a game changer. Patients I saw as part of the clinical trials achieved complete skin clearance very quickly, fulfilling a significant unmet need for this patient population."

BIMZELX Clinical Program

Health Canada's approval is based on a robust clinical program evaluating the safety and efficacy of BIMZELX in three Phase III multicenter, randomized, placebo and/or active comparator–controlled studies with 1,480 patients with moderate to severe plaque psoriasis.6 Of these, 315 patients from 37 study sites were Canadian.

  • BE VIVID: Phase III, randomized, double blind, placebo- and active-controlled, parallel-group study comparing the efficacy and safety of BIMZELX versus ustekinumab.8
  • BE READY: Phase III, randomized, double blind, placebo-controlled study investigating the efficacy and safety of BIMZELX in patients with moderate to severe plaque psoriasis, the effects of withdrawal, and two maintenance dosing schedules over 56 weeks.9
  • BE SURE: Phase III, randomized, double blind, active-controlled, parallel-group study comparing the efficacy and safety of BIMZELX with the tumor necrosis factor inhibitor adalimumab in patients with moderate to severe plaque psoriasis.10

Clinical studies involving the treatment of BIMZELX met their primary endpoints, resulting in significant improvement in the measures of disease activity compared to placebo, ustekinumab and adalimumab at Week 16.11 Significant improvements were also observed in psoriasis involving the scalp, nails, hands and feet in patients treated with BIMZELX at Week 16.12

All phase III studies also met their ranked secondary endpoints:

  • Patients trated with bimekizumab achieved superior levels of skin clearance at week 16, compared to those treated with ustekinumab, placebo and adalimumab, as measured by at least a 90 per cent improvement in the Psoriasis Area & Severity Index (PASI 90) and an Investigator's Global Assessment (IGA) response of clear or almost clear skin (IGA 0/1). Clinical responses achieved with bimekizumab at week 16 were maintained up to one year in all studies.13, 14
  • BIMZELX was superior to placebo, ustekinumab and adalimumab in achieving PASI 75 at week 4.15, 16, 17

Important and complete safety information about BIMZELX can be found by accessing the product monograph at https://www.ucb-canada.ca/BIMZELXPM The most frequent reported adverse reactions in the clinical studies were upper respiratory tract infections (14.5 per cent) (most frequently nasopharyngitis) and oral candidiasis (7.3 per cent).

About UCB Canada Inc.
Inspired by patients and driven by science, UCB Canada Inc. is a biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe autoimmune and central nervous system diseases. For more information, please consult https://www.ucb-canada.ca/.

About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 8,400 people in nearly 40 countries, the company generated revenue of €5.3 billion in 2020. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news. 

Forward looking statements UCB
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Given these uncertainties, you should not place undue reliance on any of such forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time, nor can there be any guarantee that such products will be or will continue to be commercially successful in the future.

UCB is providing this information, including forward-looking statements, only as of the date of this press release and it does not reflect any potential impact from the evolving COVID-19 pandemic, unless indicated otherwise. UCB is following the worldwide developments diligently to assess the financial significance of this pandemic to UCB. UCB expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations.

Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction. 

SOURCE UCB Canada Inc.

For further information: For further information, contact UCB: Dara Willis, Gage Communications, Email: [email protected], Phone: (416) 836-9272

References

________________

1 Canadian BIMZELX Product Monograph.

2 https://dermatology.ca/public-patients/skin/psoriasis. Accessed January 18, 2022

3 https://dermatology.ca/public-patients/skin/psoriasis. Accessed January 18, 2022

4 Moon HS, Mizara A, McBride SR. Psoriasis and psycho-dermatology. Dermatol Ther (Heidelb). 2013;3(2):117-130

5 https://dermatology.ca/public-patients/skin/psoriasis/. Accessed January 7, 2022

6 Canadian BIMZELX Product Monograph.

7 Data on File.

8 Reich K, Papp KA, Blauvelt A et al. Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled phase 3 trial. Lancet 2021; 397:487-98.

9 Gordon KB, Foley P, Krueger JG et al. Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomized withdrawal phase 3 study. Lancet 2021; 397:475-86.

10 Warren RB, Blauvelt A, Bagel J et al. Bimekizumab versus Adalimumab in Plaque Psoriasis. N Engl J Med 2021; 385:130-141.

11 Canadian BIMZELX Product Monograph.

12 BIMZELX Product Monograph.

13 Reich K, Papp KA, Blauvelt A et al. Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled phase 3 trial. Lancet 2021; 397: 487-98.

14 Gordon KB, Foley P, Krueger JG et al. Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomized withdrawal phase 3 study. Lancet 2021; 397:475-86.

15 Gordon KB, Foley P, Krueger JG et al. Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomized withdrawal phase 3 study. Lancet 2021; 397:475-86.

16 Reich K, Papp KA, Blauvelt A et al. Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled phase 3 trial. Lancet 2021; 397: 487-98.

17 Warren RB, Blauvelt A, Bagel J et al. Bimekizumab versus Adalimumab in Plaque Psoriasis. N Engl J Med 2021; 385:130-141.