Boehringer Canada Announces Availability of SPEVIGO® for expanded indication in Canada

• Generalized pustular psoriasis (GPP) is a rare, chronic, heterogenous neutrophilic inflammatory disease associated with skin and systemic symptoms, such as fever, pain, and fatigue.^1,2,3,4
• SPEVIGO's expanded indication adds a subcutaneous formulation for continuous GPP management, for GPP flare prevention in adults and pediatrics aged 12 years and older, weighing at least 40kg.⁵
• This provides full disease control: intravenous SPEVIGO treats GPP flares, while subcutaneous SPEVIGO prevents them.⁵

BURLINGTON, ON, Feb. 5, 2025 /CNW/ - Boehringer Ingelheim Canada announces that intravenous and subcutaneous supplies of SPEVIGO^® (spesolimab injection/spesolimab for injection) are now available in Canada for the treatment of generalized pustular psoriasis (GPP) in patients 12 years of age and older, weighing at least 40 kg.⁵ The subcutaneous formulation for chronic GPP treatment was granted market authorization in July 2024 by Health Canada. SPEVIGO is a novel, selective antibody that blocks the activation of the interleukin-36 receptor (IL-36R), a signalling pathway within the immune system shown to be involved in the cause of GPP.^6,7,8,9,10

The regulatory authorities' decision is based on results from the EFFISAYIL^® 2 clinical trial, a 48-week randomized, placebo-controlled study that showed that SPEVIGO significantly reduced the risk of GPP flares by 84% compared with placebo. In the trial with 123 patients, no flares were observed after week four of SPEVIGO subcutaneous treatment in the high-dose group (n=30, 600 mg loading dose; 300 mg every 4 weeks [q4w]).^11,12,13 Based on the positive results of the trial, the recommended dose of SPEVIGO for GPP flare prevention is a subcutaneous loading dose of 600 mg, followed by 300 mg every 4 weeks.⁵

"For patients living with GPP, their flares can be difficult to manage physically and emotionally," said Jensen Yeung, MD, FRCPC, dermatologist in Toronto, Ontario. "As a physician, it has been frustrating to have so little to offer patients. I'm pleased to have a new option available that provides full disease control."

GPP is a rare dermatological condition, characterized by the sudden appearance of multiple small blisters filled with sterile pus on large areas of the body referred to as a flare.⁴ There are many precipitating factors that can cause a GPP flare including, but not limited to, certain medications, steroid withdrawal, stress, excessive sun exposure, infections, and pregnancy.^14,15  Flares greatly affect a person's quality of life and can cause additional symptoms such as fever, chills, malaise, nausea and pain, or even life-threatening complications that may require emergency medical treatment.^4,9,16 

 "SPEVIGO's new expanded indication constitutes a fundamental change for people living with GPP, addressing their need for acute and chronic treatment," said Dr. Rasha Eldesouky Abouelabbas, Vice President, Medical and Regulatory Affairs, Boehringer Ingelheim (Canada) Ltd. "Therefore, expanding the treatment of GPP is a critical step towards addressing patients' needs."

About generalized pustular psoriasis (GPP)
GPP is a rare, heterogenous, and potentially life-threatening neutrophilic skin disease, which is clinically distinct from plaque psoriasis.^16,17 GPP is caused by neutrophils (a type of white blood cell) accumulating in the skin, resulting in painful, sterile pustules all over the body.¹⁸ The clinical course varies, with some patients having a relapsing disease with recurrent flares, and others having a persistent disease with intermittent flares.¹⁸ While the severity of GPP flares can vary, if left untreated they can be life-threatening due to complications such as sepsis and multisystem organ failure. This chronic, systemic disease has a substantial quality of life impact for patients and increased healthcare burden.¹⁹ 

About SPEVIGO®
SPEVIGO (spesolimab injection/spesolimab for injection) is a novel, humanized, selective antibody that blocks the activation of the interleukin-36 receptor (IL-36R), a signaling pathway within the immune system believed to be involved in the pathogenesis of several autoinflammatory diseases, including GPP. ^6,7,8,9

SPEVIGO marketing authorizations were based on clinically meaningful response rates and duration of response from the pivotal EFFISAYIL^®-1 Phase II clinical trial and positive results of the EFFISAYIL^® 2 Phase IIb clinical trial.⁵

For more information, please consult the SPEVIGO Product Monograph at www.boehringer-ingelheim.com/ca

About Boehringer Ingelheim Canada
Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. More than 53,500 employees serve over 130 markets to build a healthier, more sustainable, and equitable tomorrow. The Canadian headquarters of Boehringer Ingelheim was established in 1972 in Montreal, Quebec and is now located in Burlington, Ontario. Boehringer Ingelheim employs approximately 500 people across Canada. Learn more at www.boehringer-ingelheim.com/ca.

References:

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^1	Marrakchi S, Puig L. Pathophysiology of generalized pustular psoriasis. Am J Clin Dermatol. 2022;23:13–19.
^2	Prinz JC, Choon SE, Griffiths CEM, et al. Prevalence, comorbidities and mortality of generalized pustular psoriasis: A literature review. J Eur Acad Dermatol Venereol. 2023;37:256–273.
^3	Reisner DV, Johnsson FD, Kotowsky N, et al. Impact of generalized pustular psoriasis from the perspective of people living with the condition: Results of an online survey. Am J Clin Dermatol. 2022;23:65–71.
^4	Gooderham MJ, Van Voorhees AS, Lebwohl MG. An update on generalized pustular psoriasis. Expert Rev Clin Immunol. 2019;15:907–919.
^5	SPEVIGO Product Monograph. Available at www.boehringer-ingelheim.com/ca. July, 2024.
^6	Bassoy EY, Towne JE, Gabay C. Regulation and function of interleukin-36 cytokines. Immunol Rev. 2018;281:169–178.
^7	Marrakchi S, Guigue P, Renshaw BR, et al. Interleukin-36-receptor antagonist deficiency and generalized pustular psoriasis. N Engl J Med. 2011;365:620–628.
^8	Ganesan R, Raymond EL, Mennerich D, et al. Generation and functional characterization of anti-human and anti-mouse IL-36R antagonist monoclonal antibodies. MAbs. 2017;9:1143–1154.
^9	Bachelez H, Choon SE, Marrakchi S, et al. Trial of spesolimab for generalized pustular psoriasis. N Engl J Med. 2021;385:2431–2440.
^10	Bachelez H, Choon SE, Marrakchi S, et al. Inhibition of the interleukin-36 pathway for the treatment of generalized pustular psoriasis. N Engl J Med. 2019;380:981–983.
^11	Morita A, Strober B, Burden AD, et al. Efficacy and safety of subcutaneous spesolimab for the prevention of generalised pustular psoriasis flares (Effisayil 2): an international, multicentre, randomised, placebo-controlled trial. Lancet. 2023;402:1541–1551.
^12	Gordon KB, Lebwohl M, Barker J, et al. Effect of spesolimab on achieving sustained disease remission in patients with generalized pustular psoriasis: Results from the Effisayil 2 study. European Academy of Dermatology & Venereology Congress; 2023; Berlin, Germany. Abstract P0731.
^13	Strober B, Augustin M, Tada Y, et al. Effect of high-dose subcutaneous spesolimab on skin manifestations: Results from the pivotal Effisayil 2 trial of flare prevention in generalized pustular psoriasis. European Academy of Dermatology & Venereology Congress; 2023; Berlin, Germany. Abstract 1732.
^14	Strober B, Kotowsky N, Medeiros R, et al. Unmet medical needs in the treatment and management of generalized pustular psoriasis flares: evidence from a survey of Corrona registry dermatologists. Dermatol Ther (Heidelb). 2021;11(2):529-541.
^15	Kharawala S, Golembesky AK, Bohn RL, Esser D. The clinical, humanistic, and economic burden of generalized pustular psoriasis: a structured review. Expert Rev Clin Immunol. 2020;16(3):239-252.
^16	Crowley JJ, et al. A brief guide to pustular psoriasis for primary care providers, Postgrad Med. 2021;133(3):330-344.
^17	Puig L, et al. Global consensus on the clinical course, treatment and management of generalized pustular psoriasis (GPP). Presented at the European Academy of Dermatology and Venereology (EADV) Congress, Milan, Italy, 7–10 September 2022: P1203.B.
^18	Navarini AA, et al. European consensus statement on phenotypes of pustular psoriasis. JEADV. 2017;31:1792-1799.
^19	Hanna M, et al. Economic burden of generalized pustular psoriasis and palmoplantar pustulosis in the United States. Curr Med Res Opin. 2021. 37(5):735-742.

SOURCE Boehringer Ingelheim Canada Ltd.

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