The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of a new indication for Boehringer Ingelheim’s Spevigo® (spesolimab) injection. This recommendation includes its use for preventing generalized pustular psoriasis (GPP) flares in adults and adolescents aged 12 years and older. The CHMP also endorsed an extension of the approved use of Spevigo® infusion for treating GPP flares as a standalone therapy in the same age group.
Spevigo® is a novel humanized selective IgG1 antibody that targets the interleukin-36 receptor (IL-36R), a critical component of the immune system’s signaling pathway involved in GPP. The CHMP’s decision is based on the positive results from the EFFISAYIL® 2 trial, a 48-week study that showed Spevigo® reduced the risk of GPP flares by 84% compared to a placebo. In the trial, involving 123 patients, no flares were observed after week 4 in the high-dose Spevigo® group. Adverse events were reported at similar rates in both the Spevigo® and placebo groups.
GPP is a rare, chronic inflammatory disease distinct from plaque psoriasis, marked by painful skin lesions and systemic symptoms like fever, pain, and fatigue. The unpredictable nature of GPP can lead to serious complications, including multi-organ failure and sepsis, which significantly affect patients’ quality of life and cause considerable anxiety. Dr. Peter van der Kerkhof from Radboud University Nijmegen Medical Centre remarked, “GPP is a challenging and rare condition with few treatment options historically. The new approvals and CHMP recommendation for spesolimab provide an opportunity for ongoing treatment and address a major unmet need.”
Carinne Brouillon, Member of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim, stated, “The CHMP’s positive opinion, along with recent approvals in China and the US, marks a significant step forward in treatment options. It offers the potential to prevent GPP flare-ups and improve patient quality of life.” Frida Dunger, Executive Director of the International Federation of Psoriasis Associations (IFPA), added, “GPP impacts all areas of a person’s life. Our goal is to ensure timely diagnosis and effective treatment for everyone with GPP. While there is still much work to be done, we are making progress with the collaboration of all stakeholders.”
Related topics:
