Committee Recommends Expanded Indications for Spesolimab, Targeting Generalized Pustular Psoriasis
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval expanded indications for spesolimab (SPEVIGO®), according to a press release.
A humanized selective IgG1 antibody targeting the interleukin-36 receptor (IL-36R), spesolimab is currently approved in 51 countries for the treatment of generalized pustular psoriasis (GPP) flares. The Committee's recommendation includes new approvals for preventing GPP flares in adults and adolescents aged 12 and older, as well as extending its approved use as a monotherapy for GPP flares in the same age group.
“GPP presents a significant diagnostic challenge for healthcare professionals as it is a highly variable rare disease that is experienced differently by everyone who has it, and it has suffered from a historic lack of treatment options,” said Dr Peter van der Kerkhof, Professor and previous Chairman of the Department of Dermatology, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands, in a news release from Boehringer Ingelheim. “Spesolimab’s recent approvals, combined with the CHMP recommendation provides us with the potential for continuous treatment, addressing a significant unmet need.”
The recommendation is based on the EFFISAYIL 2 clinical trial, the results of which showed a significant (84%) reduction in the risk of GPP flares over 48 weeks, with no flares observed after the fourth week of subcutaneous spesolimab administration in the high-dose group. The trial included 123 participants and found a similar incidence of adverse events in both the spesolimab and placebo groups.
"GPP goes way beyond the skin, it's a relentless and unpredictable disease that can impact every aspect of a person's life,” said Frida Dunger, Executive Director, IFPA (International Federation of Psoriasis Associations), in the press release. “I want a world where every person with GPP is diagnosed quickly and receives the treatment they need, and this is their right. There is much more to do, but I believe with all stakeholders working together we are headed in the right direction.”
Source: Boehringer Ingelheim press release. July 29, 2024.