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FDA Expands Indication for Boehringer Ingelheim’s Spevigo in Generalized Pustular Psoriasis


Indication of Spevigo (spesolimab-sbzo) expanded for the treatment of generalized pustular psoriasis in patients 12 years of age and older weighing ≥40 kg.

Image credit: Calin | stock.adobe.com

Image credit: Calin | stock.adobe.com

The FDA has approved an expanded indication for Boehringer Ingelheim’s Spevigo (spesolimab-sbzo) to treat generalized pustular psoriasis (GPP) in patients 12 years of age and older weighing ≥40 kg.1 The humanized, selective IgG1 antibody targets a pathogenic immune system signaling pathway, which has been found to prevent flares in adolescents and adults with GPP.2 The drug attaches to the interleukin-36 receptor (IL-36R), which is a key portion of the signaling pathway found to be involved in the manifestation of GPP.

“Until now, people living with GPP have not had any approved options to treat their disease,” Bruce Strober, MD, PhD, clinical professor, Dermatology, Yale University and Central Connecticut Dermatology, said in a press release. “Spevigo has the potential to redefine the treatment options for the patients we serve.”1

GPP is a rare, chronic, heterogenous, inflammatory neutrophilic disease with clinical differences from plaque psoriasis. The disease is caused by the accumulation of white blood cells, leading to painful, sterile pustules and systemic symptoms, including fever, pain, and fatigue. GPP typically involves unpredictable recurrent or intermittent flares that, if left untreated, can result in life-threatening sepsis, renal failure, or multisystem organ failure.2

The FDA based the approval primarily on findings from the 48-week, multicenter, randomized, double-blind, placebo-controlled Phase II EFFISAYIL 2 trial (NCT04399837). Among 123 patients in the trial, those administered subcutaneous Spevigo in the high-dose group (n=30) did not experience any flares after week four.

The drug was found to significantly lower the risk of GPP flares by 84% compared with placebo. The effects of Spevigo lasted for 11 months following treatment in both adolescent and adult patient populations. Findings from the Phase II EFFISAYIL 1 trial found that a single intravenous (IV) dose of Spevigo was able to significantly improve the signs and symptoms of GPP in patients experiencing a flare, including rapid pustular and skin clearance.2

The EFFISAYIL clinical trial program was developed to evaluate Spevigo as a preventative therapy across a range of patients with GPP.

Spevigo treatment over 12 weeks was found to significantly improve skin and pustular clearance, leading to the drug becoming the first GPP flare-specific treatment available in the United States, Japan, Mainland China, and European Union markets.

In Effisayil 2, treatment with Spevigo was linked to increased incidence (≥9 cases per 100 patient-years) of injection site reaction, urinary tract infection (UTI), arthralgia, and pruritus compared to placebo. The most common adverse effects (AEs) associated with IV administration of Spevigo include fatigue; nausea and vomiting; headache; itching or itchy bumps; blood collecting under the skin at the infusion site or bruising; and UTI. The most common AEs associated with subcutaneous administration of Spevigo when not experiencing a flare include redness, pain, swelling, hardening, hives, or warmth at the injection site; joint pain; UTI; and itching.

“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, in a press release. “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.”1


1. SPEVIGO® approved for expanded indications in China and the US. Boehringer Ingelheim. News release. March 19, 2024. Accessed March 19, 2024. https://www.boehringer-ingelheim.com/human-health/skin-diseases/gpp/spevigo-approved-expanded-indications-china-us

2. Spesolimab meets primary and key secondary endpoint for prevention of generalized pustular psoriasis flares. News Release. January 30, 2023. Accessed March 19, 2024. https://www.boehringer-ingelheim.com/human-health/skin-diseases/gpp/spesolimab-meets-key-endpoint-for-gpp-flare-prevention

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