Vitiligo, affecting over 90 per cent of patients in its non-segmental form, is characterized by symmetrical white patches on both sides of the body
Approval based on pivotal KOMET Phase III trial demonstrating significant tumour reduction in adults with NF1
The positive opinion is based on results from KOMET, the largest and only placebo-controlled, double-blind global Phase III trial in this patient population
The Phase 3 data presented at AAD include a comprehensive review of the THRIVE-AA2 results and further elaborate the topline data reported in August 2022
CHMP positive opinion is based on evidence from the EFFISAYIL trial, the largest clinical trial in
Spesolimab is a monoclonal antibody that inhibits interleukin-36 (IL-36) signaling and is the first treatment specifically approved for the treatment of generalized pustular psoriasis flares
Clinical improvements were consistent across patient subgroups including age, gender, ethnicity, and IL-36 gene mutation status
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