Boehringer Ingelheim today announced that the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of a new indication of SPEVIGO® (spesolimab) injection for the prevention of generalized pustular psoriasis (GPP) flares in adults and adolescents from 12 years of age; and extension of the approved indication for SPEVIGO® (spesolimab) infusion for the treatment of generalized pustular psoriasis (GPP) flares in adults and adolescents from 12 years of age as monotherapy. SPEVIGO® is a novel, humanized selective IgG1 antibody that binds to interleukin-36 receptor (IL-36R), a key part of a signaling pathway within the immune system shown to be involved in the cause of GPP.
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CHMP adopts positive opinion recommending approval of new and expanded indications for SPEVIGO®
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