FDA Approves Boehringer Ingelheim's Spesolimab-sbzo For Adults and Children With Generalized Pustular Psoriasis

Boehringer Ingelheim announced today¹ the expanded US Food and Drug Administration (FDA) approval of its spesolimab-sbzo (Spevigo) injection for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients aged 12 and above weighing ≥40 kg.

The approval follows a recent similar action from the Chinese National Medical Products Administration (NMPA), where the NMPA garnered approval for reducing the occurrences of GPP in adolescents and adults. Spesolimab-sbzo, a humanized selective IgG1 antibody with its unique mechanism of action targeting the interleukin-36 receptor (IL-36R), stands as the first targeted therapy to address the acute and chronic treatment needs of GPP patients.

The expanded approval decisions are rooted in positive results from the Effisayil 2 clinical trial,² a pivotal 48-week study that demonstrated spesolimab-sbzo's efficacy in mitigating GPP flares. Tthe trial showcased an 84% reduction in the risk of GPP flares when compared to placebo. Furthermore, the high-dose group of spesolimab-sbzo exhibited an outcome with no observed flares after the fourth week of subcutaneous treatment. Associated adverse events, including injection site reactions, urinary tract infections, arthralgia, and pruritus, albeit at a higher incidence compared to the placebo arm, were noted.

Reflecting on the potential of spesolimab-sbzo, Bruce Strober, MD, PhD, clinical professor of dermatology at Yale University and Central Connecticut Dermatology and a study author of the Effisayil 2 clinical trial, said in the news release,¹ “Until now, people living with GPP have not had any approved options to treat their disease. Spevigo has the potential to redefine the treatment options for the patients we serve.”

Carinne Brouillon, PharmD, member of the Board of Managing Directors and head of Human Pharma at Boehringer Ingelheim, underscored the significance of these new approvals, emphasizing the profound impact on patients' lives.

"Experiencing GPP can be mentally and physically devastating, leaving those affected with uncertainty and fear of the next episode," Brouillon said.¹ "Therefore, expanding the treatment of GPP is a critical step towards addressing patients’ needs."

In September 2022, Boehringer Ingelheim announced that the FDA had approved spesolimab-sbzo for generalized pustular psoriasis flares in adult patients, making it the first approved treatment option for this indication.³

References

1. Spevigo approved for expanded indications in China and the US. News release. Boehringer Ingelheim. March 19, 2024. Accessed March 19, 2024. https://www.boehringer-ingelheim.com/us/spevigo-approved-expanded-indications-china-and-us
2. Morita A, Strober B, Burden D, 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. September 19, 2023. Accessed March 19, 2024. DOI:https://doi.org/10.1016/S0140-6736(23)01378-8PlumX Metrics
3. FDA approves the first treatment option for generalized pustular psoriasis flares in adults. News release. Boehringer Ingelheim. September 1, 2022. Accessed March 19, 2024. https://www.boehringer-ingelheim.com/us/press-release/fda-approves-first-treatment-option-generalized-pustular-psoriasis-flares-adults