FDA Grants Approval to Boehringer Ingelheim’s Spesolimab for GPP Flares

The FDA has given approval to Boehringer Ingelheim’s spesolimab for generalized pustular psoriasis (GPP) flares in adults.

This is the first approval for a treatment for GPP, a rare and severe form of psoriasis that’s potentially life-threatening.

The approval was based on results from a phase 2 clinical trial in which 54 percent of patients treated with Spevigo intravenously showed no visible pustules after a week compared with 6 percent of patients taking placebo.

The drug, which will be marketed in the U.S. as Spevigo, operates as a selective antibody that blocks the activation of the interleukin-36 receptor (IL-36R), a signaling pathway within the immune system involved in the pathogenesis of GPP.