The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended approving a new indication for Boehringer Ingelheim’s Spevigo (spesolimab) injection. This approval aims to prevent generalised pustular psoriasis (GPP) flares in adults and adolescents aged 12 and older.
Spevigo was initially approved by the European Commission in December 2022 for treating GPP flares in adults as a monotherapy. The new recommendation extends the use of Spevigo to younger patients for preventing flare-ups.
Spevigo works by targeting the interleukin-36 receptor (IL-36), a critical component in the immune system’s signaling pathway implicated in GPP’s pathogenesis.
GPP is a rare and severe type of psoriasis characterized by widespread pustules on red skin, often accompanied by systemic symptoms such as fever and fatigue. Unlike other forms of psoriasis, GPP can become life-threatening due to complications like sepsis and multisystem organ failure. Boehringer Ingelheim asserts that Spevigo addresses the underlying cause of GPP, rather than merely alleviating symptoms.
The CHMP’s recommendation is based on positive results from the Phase IIb EFFISAYIL 2 trial (NCT04399837). In this trial, Spevigo significantly reduced the risk of GPP flare-ups by 84% over 48 weeks compared to a placebo. Among the 123 patients in the trial, no flares were observed after week four in the high-dose group receiving Spevigo subcutaneously.
In May 2023, Spevigo received breakthrough therapy designation from the US Food and Drug Administration (FDA) 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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