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SPEVIGO® approved for expanded indications in China and the US

AGÊNCIA DE COMUNICAÇÃO Conteúdo de responsabilidade da empresa 19 de março de 2024

Boehringer Ingelheim

Boehringer Ingelheim today announced that the US Food and Drug Administration (FDA) has approved SPEVIGO® (spesolimab-sbzo) injection for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients aged 12 and above weighing 40 kg.5 This approval follows the Chinese National Medical Products Administrations (NMPA) recent approval of SPEVIGO® for the reduction of occurrence of generalized pustular psoriasis (GPP) in adolescents from 12 years of age with a body weight 40 kg and adults. SPEVIGO® is a novel, humanized selective IgG1 antibody that binds to interleukin-36 receptor (IL-36R), a key part of a signaling pathway within the immune system shown to be involved in the cause of GPP.8,9,10,11,12

The regulatory authorities decisions are majorly based on the positive results of the EFFISAYIL® 2 clinical trial, a 48-week clinical trial 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 4 of SPEVIGO® subcutaneous treatment in the high-dose group (n=30).13,14,15,16 In the Effisayil® 2 trial, SPEVIGO® was associated with an increased incidence (9 cases per 100 patient-years) of injection site reaction, urinary tract infection, arthralgia, and pruritus compared to placebo.

Until now, people living with GPP have not had any approved options to treat their disease, said Bruce Strober, MD, PhD, Clinical Professor, Dermatology, Yale University and Central Connecticut Dermatology. SPEVIGO® has the potential to redefine the treatment options for the patients we serve.

Distinct from plaque psoriasis, GPP is a rare, chronic, heterogenous, inflammatory neutrophilic disease associated with painful skin manifestations and systemic symptoms, such as fever, pain, and fatigue.1-4 GPP varies widely between individuals living with the condition, with symptoms presenting on a continuum, which means that it can present in either a persistent or a relapsing course.2-4 GPP often requires emergency care and can lead to life-threatening complications, such as multi-organ failure and sepsis.17 GPPs unpredictable nature can potentially have significant long-term impacts on quality of life for people living with it, and may cause fear and anxiety over the disease course.3,18

SPEVIGO®s new approvals constitute a fundamental change for people living with GPP, addressing their huge need for acute and chronic treatment, said Carinne Brouillon, Member of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim. Experiencing GPP can be mentally and physically devastating, leaving those affected with uncertainty and fear of the next episode. Therefore, expanding the treatment of GPP is a critical step towards addressing patients needs.

About SPEVIGO®

SPEVIGO® is a novel, humanized, selective antibody that specifically blocks the activation of the IL-36R, a signaling pathway within the immune system shown to be involved in the pathogenesis of several autoinflammatory diseases, including GPP.7-11 It is the first targeted therapy for the treatment of GPP and has been evaluated in the largest clinical program specifically for the treatment of patients with GPP.10,19

What is SPEVIGO®?

SPEVIGO® is a prescription medicine used to treat generalized pustular psoriasis (GPP) in adults and children 12 years of age and older who weigh at least 88 pounds (40 kg). It is not known if SPEVIGO® is safe and effective in children under 12 years of age or who weigh less than 88 pounds.

Important Safety Information

Do not receive SPEVIGO® if you or your child have had a severe or life-threatening allergic reaction to spesolimab-sbzo or any of the ingredients in SPEVIGO®.

What is the most important information I should know about SPEVIGO®? SPEVIGO® may cause serious side effects, including:

Before you or your child receive SPEVIGO®, tell your healthcare provider about all of your medical conditions, including if you or your child:

Tell your healthcare provider about all the medicines you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of SPEVIGO®?

The most common side effects of SPEVIGO® given in a vein (intravenously) for GPP flare treatment include:

The most common side effects of SPEVIGO® when given under the skin (subcutaneously) for treatment of GPP when not experiencing a flare include:

These are not all of the possible side effects of SPEVIGO®. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1800FDA1088.

Please see full Prescribing InformationMedication Guide, and Instructions for Use.

CL-SPG-100004 03.18.2024

About the EFFISAYIL® clinical trial program

The EFFISAYIL® clinical trial program evaluated the largest and broadest population of GPP patients in trials of a therapy specifically targeting the IL-36 pathway for GPP:10,18

About generalized pustular psoriasis (GPP)

GPP is a chronic, heterogenous, neutrophilic inflammatory disease associated with skin and systemic symptoms that is distinct from plaque psoriasis. GPP is recognized as a separate clinical entity from other forms of psoriasis, with the IL-36 pathway being a key driver of GPP and triggering response to treatment.1 Prevalence of GPP is low and varies considerably across geographical regions, ranging from 1.76 to 124 patients per million persons in reports from key countries, including France, Japan, Sweden, and South Korea.2 GPP can become life-threatening (mortality rates ranging from 2% to 16%) due to severe complications, such as multisystem organ failure and sepsis requiring urgent hospital care; many GPP patients also suffer from various comorbidities, which contribute to the ongoing burden for the patient and healthcare systems.2,16,17 GPP symptoms appear unpredictable and present on a continuum, which greatly impacts a patients quality of life, and may cause fear and anxiety over the disease course, as well as long-term impacts on quality of life related to work/school, emotional health, social activities, and finances.2,3,4

About Boehringer Ingelheim

Boehringer Ingelheim is working on breakthrough therapies that transform lives today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term, sustainable perspective. More than 53,000 employees serve over 130 markets in the two business units, Human Pharma and Animal Health. Learn more at https://www.boehringer-ingelheim.com/.

March 2024
MPR-CRP-100327, MPR-US-102903

References:

1Marrakchi S, Puig L. Pathophysiology of generalized pustular psoriasis. Am J Clin Dermatol. 2022;23:1319.

2Prinz JC, Choon SE, Griffiths CEM, et al. Prevalence, comorbidities and mortality of generalized pustular psoriasis: A literature review. J Eur Acad Dermatol Venereol. 2023;37:256273.

3Reisner 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;23:6571.

4Gooderham MJ, Van Voorhees AS, Lebwohl MG. An update on generalized pustular psoriasis. Expert Rev Clin Immunol. 2019;15:907919.

5National Medical Products Administration. Drug approval document release, March 11 2024. 20240311 (nmpa.gov.cn) (Accessed 14 March 2024)

6Record on file.

7Record on file.

8Bassoy EY, Towne JE, Gabay C. Regulation and function of interleukin-36 cytokines. Immunol Rev. 2018;281:169178.

9Marrakchi S, Guigue P, Renshaw BR, et al. Interleukin-36-receptor antagonist deficiency and generalized pustular psoriasis. N Engl J Med. 2011;365:620628.

10Ganesan R, Raymond EL, Mennerich D, et al. Generation and functional characterization of anti-human and anti-mouse IL-36R antagonist monoclonal antibodies. MAbs. 2017;9:11431154.

11Bachelez H, Choon SE, Marrakchi S, et al. Trial of spesolimab for generalized pustular psoriasis. N Engl J Med. 2021;385:24312440.

12Bachelez 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;380:981983.

13Boehringer Ingelheim. Spesolimab prevented generalized pustular psoriasis flares in Effisayil 2 trial. 2023. https://www.boehringer-ingelheim.com/us/press-releases/effisayil-2-trial-results. (Accessed 14 March 2024).

14Morita 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;402:15411551.

15Gordon 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.

16Strober 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.

17Choon SE, Navarini AA, Pinter A. Clinical course and characteristics of generalized pustular psoriasis. Am J Clin Dermatol. 2022;23:2129.

18Burden D, Mrowietz U, Skalicky AM, et al. Symptom experience and content validity of the Psoriasis Symptom Scale (PSS) in patients with generalized pustular psoriasis (GPP). Dermatol Ther (Heidelb). 2022;12:13671381.

19Choon SE, Lebwohl MG, Marrakchi S, et al. Study protocol of the global Effisayil 1 Phase II, multicentre, randomised, double-blind, placebo-controlled trial of spesolimab in patients with generalized pustular psoriasis presenting with an acute flare. BMJ Open. 2021;11:e043666.

20Navarini A, Prinz JC, Morita A, et al. Spesolimab improves patient- reported outcomes in patients with generalized pustular psoriasis: Results from the Effisayil 1 study. J Eur Acad Dermatol Venereol. 2022; 37:730736.

21Effisayil ON: A study to test long-term treatment with spesolimab in people with generalized pustular psoriasis who took part in a previous study. https://clinicaltrials.gov/study/NCT03886246. (Accessed 14 March 2024).



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