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# FDA Approves Boehringer Pustular Psoriasis Drug
- URL: https://www.fdaweb.com/fda-approves-boehringer-pustular-psoriasis-drug/
- Published: 2022-09-02T12:00:00.000Z
- Updated: 2026-09-14T17:58:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152660

FDA has approved a Boehringer Ingelheim NDA for Spevigo (spesolimab) as a treatment option for generalized pustular psoriasis (GPP) flares in adults. The novel, selective antibody is said to work by blocking the activation of the interleukin-36 receptor (IL-36R), a signaling pathway within the immune system shown to be involved in the pathogenesis of GPP, the company says. 

Approval was based on data from the FFISAYIL 1 Phase 2 clinical trial. “Most patients at the outset of the trial had a high, or very high, density of pustules, and impaired quality of life,” Boehringer says. “After one week, 54% of patients treated with spesolimab showed no visible pustules compared to placebo (6%).”