Spesolimab for the treatment of flares of generalized pustular psoriasis receives U.S. FDA approval

The U.S. Food and Drug Administration (FDA) has announced the approval of spesolimab for the treatment of flares of generalized pustular psoriasis (GPP) in adults.¹

Spesolimab is the first agent approved for this indication and has already been granted breakthrough therapy designation in the US, China, and Taiwan, along with orphan drug designation in Korea, Switzerland, Australia, and the US. In Europe, the marketing authorization application for spesolimab was validated by the European Medicines Agency in 2021 and the request is currently being assessed.¹

Spesolimab is a monoclonal antibody that binds to and inhibits the interleukin-36 receptor, which is involved in the signaling pathways in GPP. GPP, which may be life-threatening if untreated, is a neutrophilic condition characterized by pustules all over the body that lead to pain and poor quality of life. In addition to the treatment of GPP flares, spesolimab is being examined as a prophylactic agent for GPP flares and for the treatment of hidradenitis suppurativa and palmoplantar pustulosis.

The U.S. FDA approval comes following data from a phase II clinical trial (NCT03782792). During this 12-week trial, spesolimab (900 mg intravenous) was tested in patients with GPP flares (N = 53) and compared with placebo. The results of this trial found 54% of patients treated with spesolimab demonstrated no visible pustules, compared with 6% of patients treated with placebo. After 1 week of treatment, 66% of patients in the spesolimab group reported adverse events, compared with 56% in the placebo group; this included infections in 17% and 6% of the spesolimab and placebo groups, respectively. The rate of serious adverse events in the spesolimab group was 6%.