• 21 Mar 2024
• Admin
• News Article

Boehringer’s Spevigo Gets Expanded Indication Approval

Boehringer Ingelheims Spevigo receives approval for expanded indication in China & US

Overview 

Boehringer Ingelheim 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 paediatric patients aged 12 and above weighing =40 kg. This approval follows the Chinese National Medical Products Administration’s (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 Target Receptor

Spevigo is a novel, humanized selective IgG1 antibody that binds to interleukin-36 receptor (IL-36R), a key part of a signalling pathway within the immune system shown to be involved in the cause of GPP.

EFFISAYIL 2 Clinical Trial

• 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). 
• 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.

Words from , Yale University

“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.”

About GPP

• 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. 
• 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. 
• GPP often requires emergency care and can lead to life-threatening complications, such as multi-organ failure and sepsis. 
• GPP’s 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.

Words from Boehringer Ingelheim

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.”

Aabout Spevigo

• Spevigo is a novel, humanized, selective antibody that specifically blocks the activation of the IL-36R, a signalling pathway within the immune system shown to be involved in the pathogenesis of several autoinflammatory diseases, including GPP. 
• 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.
• 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.

EFFISAYIL Clinical Trial

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:

EFFISAYIL 1: 

• A phase II study that demonstrated treatment with a single intravenous dose of spesolimab significantly improved signs and symptoms of GPP in patients experiencing a flare, including rapid pustular and skin clearance. 
• These results supported the approval of spesolimab as the first specific treatment for GPP flares in adults in major markets.

EFFISAYIL 2: 

• A phase IIb study that showed spesolimab significantly reduced the risk of GPP flares by 84% over 48 weeks compared to placebo. 
• In the trial with 123 patients, no flares were observed after week 4 of spesolimab SC treatment  in the high-dose group (n=30)

EFFISAYIL ON: 

• An open-label extension study to evaluate the long-term safety and efficacy of spesolimab in patients with GPP who have completed previous spesolimab trials.

Details on 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. 
• Prevalence of GPP- 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. 
• 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. 
• GPP symptoms appear unpredictable and present on a continuum, which greatly impacts a patient’s 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.

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.