Home Dermatology FDA Approves SPEVIGO for Generalized Pustular Psoriasis Flares

FDA Approves SPEVIGO for Generalized Pustular Psoriasis Flares

The monoclonal antibody infusion is approved for use in adults

TUESDAY, Sept. 6, 2022 (HealthDay News) — The U.S. Food and Drug Administration has approved SPEVIGO (spesolimab-sbzo) as the first treatment option for generalized pustular psoriasis (GPP) flares in adults.

SPEVIGO is a novel, selective antibody infusion that blocks the activation of the interleukin-36 receptor, which is part of an immune system signaling pathway thought to be involved in the cause of GPP. The approval was based on a 12-week trial in which 53 patients with a GPP flare were treated with SPEVIGO or placebo. After one week, more patients treated with SPEVIGO showed no visible pustules than those treated with placebo (54 versus 6 percent).

The most common adverse reactions (≥5 percent) reported in patients taking SPEVIGO were asthenia and fatigue, nausea and vomiting, headache, pruritus and prurigo, infusion site hematoma and bruising, and urinary tract infection.

“GPP flares can greatly impact a patient’s life and lead to serious, life-threatening complications,” Mark Lebwohl, M.D., lead investigator for the trial, said in a statement. “The approval of SPEVIGO is a turning point for dermatologists and clinicians.”

Approval of SPEVIGO was granted to Boehringer Ingelheim.

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