The EMA’s CHMP has approved the expansion of the label for Boehringer Ingelheim’s Spevigo (spesolimab) to include younger patients. Credit: Shutterstock/T. Schneider

The European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of a new indication of Boehringer Ingelheim’s Spevigo (spesolimab) injection for the prevention of generalised pustular psoriasis (GPP) flares in adults and adolescents from 12 years of age.

Spevigo originally received a European Commission approval for the infusion in December 2022, for the treatment of GPP flares in adults as a monotherapy. However, this approval would offer younger patients the chance to use Spevigo to prevent flare-ups.

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Spevigo attaches to the interleukin-36 receptor (IL-36), which plays a crucial role in the immune system’s signalling pathway and is implicated in the pathogenesis of GPP.

GPP is a rare, severe type of psoriasis where patients suffer from widespread pustules on red skin, often accompanied by systemic symptoms like fever and fatigue. It is distinct from other forms of psoriasis, as it can become life-threatening due to complications like sepsis and multisystem organ failure. As per the company, Spevigo treats the underlying cause of GPP, rather than just treating the symptoms.

The CHMP recommendation is based on the positive results of the Phase IIb EFFISAYIL 2 trial (NCT04399837), where Spevigo significantly reduced the risk of GPP flare-ups by 84% over 48 weeks compared to placebo. In the trial with 123 patients, no flares were observed after week four of Spevigo subcutaneous treatment in the high-dose group.

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Spesolimab received a breakthrough therapy designation from the US Food and Drug Administration (FDA) in May 2023 and the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) as an investigational treatment for flare prevention.

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Spevigo is the only treatment that has been approved by the FDA specifically to treat flares of GPP. Though yet to be approved, its biggest competitor will be AnapstysBio’s imsidolimab, which also targets the IL-36 receptor. Phase III data of imsidolimab demonstrated that rapid clearance of GPP was observed in 53.3% of the participants that had been administered with 750mg intravenous imsidolimab at week four, meeting the primary endpoint.

In the announcement accompanying the recommendation, head of human pharma at Boehringer Carinne Brouillon said: “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.”