FDA green lights Spevigo, first treatment option for GPP flares in adults

2 September 2022
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The US Food and Drug Administration (FDA) has approved Spevigo (spesolimab-sbzo), the first approved treatment option for generalized pustular psoriasis s (GPP) flares in adults, developed by German family-owned pharma major Boehringer Ingelheim.

Spevigo is a novel, selective antibody that blocks the activation of the 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.

Dr Mark Lebwohl, lead investigator and publication author, and Dean for Clinical Therapeutics, Icahn School of Medicine at Mount Sinai, Kimberly and Eric J. Waldman Department of Dermatology, New York, commented: “The approval of Spevigo is a turning point for dermatologists and clinicians. We now have an FDA-approved treatment that may help make a difference for our patients who, until now, have not had any approved options to help manage GPP flares.”

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