Approval has been recommended by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for new and expanded indications of SPEVIGO® (spesolimab) by Boehringer Ingelheim Pharmaceuticals. This decision is based on the EFFISAYIL® 2 trial, which showed that no flares were observed after week 4 of SPEVIGO® administered subcutaneously. During the 48-week trial, an 84% reduction in the risk of generalized pustular psoriasis (GPP) flares was observed.
GPP is a rare, chronic, heterogeneous neutrophilic inflammatory disease associated with skin flares and systemic symptoms such as fever, pain, and fatigue. SPEVIGO® is currently approved in 51 countries for the treatment of GPP flares, and the CHMP’s positive opinion follows similar approvals for expanded and new indications in the US and China.
The regulatory authorities’ decisions are based on the positive results of the EFFISAYIL® 2 trial, a 48-week clinical trial involving 123 patients. The trial demonstrated that SPEVIGO® significantly reduced the risk of GPP flares by 84% compared with placebo. No flares were observed after week 4 of SPEVIGO® subcutaneous treatment in the high-dose group. The trial also showed a similar incidence of adverse events across both spesolimab and placebo treatment arms.
“GPP presents a significant diagnostic challenge for healthcare professionals as it is a highly variable rare disease that is experienced differently by everyone who has it, and it has suffered from a historic lack of treatment options,” said Dr. Peter van der Kerkhof, Professor and previous Chairman of the Department of Dermatology, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands. “Spesolimab’s recent approvals, combined with the CHMP recommendation, provide us with the potential for continuous treatment, addressing a significant unmet need.”
Approval for SPEVIGO®: Addressing the Complex and Severe Impact of GPP
Distinct from plaque psoriasis, GPP is a rare, chronic, heterogeneous, 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 both above and below the skin. Uncontrolled GPP may require emergency care and can lead to life-threatening complications such as multi-organ failure and sepsis. The unpredictable nature of GPP can significantly impact the quality of life for those living with it, leading to fear and anxiety over the disease course.
“The CHMP’s positive opinion on SPEVIGO®, alongside approvals in China and the US, signals a strong shift in treatment, offering people living with the disease the potential for significant improvement of their condition and a better quality of life,” said Carinne Brouillon, Member of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim. “The potential to prevent GPP flare-ups means a possibility to gain back control over how people affected by the disease live their lives.”
“GPP goes way beyond the skin; it’s a relentless and unpredictable disease that can impact every aspect of a person’s life,” said Frida Dunger, Executive Director, IFPA (International Federation of Psoriasis Associations). “I want a world where every person with GPP is diagnosed quickly and receives the treatment they need, and this is their right. There is much more to do, but I believe with all stakeholders working together, we are headed in the right direction.”
Resource: Boehringer Ingelheim, July 29, 2024

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