Boehringer Ingelheim discovered novel spesolimab (marketed as SPEVIGO®) for the prevention of flares in adolescents and adults with generalised pustular psoriasis (GPP).
Spesolimab, a novel humanised selective antibody, has emerged as a significant advancement in the treatment of generalised pustular psoriasis (GPP). By blocking the activation of the interleukin-36 receptor (IL-36R), a key signalling pathway implicated in the development of various autoinflammatory diseases, including GPP, spesolimab offers a targeted therapeutic approach.
Spesolimab represents a significant milestone as the first approved treatment for GPP flares that directly focuses on the IL-36 pathway.
Its unique mechanism of action is thoroughly evaluated in a robust clinical trial, employing statistical power and randomisation with a placebo-controlled design. This rigorous assessment has demonstrated efficacy and safety in the management of GPP flares.
Notably, it has gained regulatory approval in nearly 40 countries, including the United States, Japan, Mainland China, and the European Union, for the management of GPP flares in adults.
Generalised pustular psoriasis (GPP) flares can appear suddenly, escalate rapidly, and pose a potentially life-threatening situation if not addressed promptly. This unsettling reality leaves individuals affected by GPP feeling anxious and uncertain about their future.
U.S. FDA has granted breakthrough therapy designation for spesolimab.
