Boehringer Ingelheim gets European Commission approval for Generalized Pustular Psoriasis flares treatment Spesolimab
People living with GPP often do not receive a correct or timely diagnosis and may have their symptoms identified as other forms of psoriasis.
Ingelheim: Boehringer Ingelheim has recently announced that the European Commission (EC) has granted a conditional marketing authorization for the company's spesolimab as first in class treatment for GPP flares in adults.
Spesolimab is a novel, selective antibody that blocks 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 EC's conditional approval of spesolimab is based on results from the pivotal EFFISAYIL 1 Phase II clinical trial. In the 12-week trial, patients experiencing a GPP flare were treated with spesolimab or placebo. Most patients at the outset of the trial had a moderate or severe pustulation of the skin. After one week, 54% of patients treated with a single dose of spesolimab showed no visible pustules compared to placebo (6%). Infections were reported by 17% and 6% of patients in the spesolimab and placebo groups respectively (at week one).
People living with GPP often do not receive a correct or timely diagnosis and may have their symptoms identified as other forms of psoriasis. A Global Delphi Consensus Project classified GPP as phenotypically, genetically, immunologically, and histopathologically distinct from psoriasis vulgaris / plaque psoriasis based on a systematic literature review. The growing list of regulatory approvals for spesolimab for the treatment of GPP flares underlines that the Delphi panel's vision of improved diagnosis and treatment for people with GPP is increasingly achievable.
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