SPEVIGO approved expanded indications China US
SPEVIGO® approved for expanded indications in China and the US
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SPEVIGO CHMP positive opinion new indications
CHMP adopts positive opinion recommending approval of new and expanded indications for SPEVIGO®
SPEVIGO (spesolimab) wins 2023 Prix Galien USA Award
SPEVIGO® (spesolimab) wins 2023 Prix Galien USA Best Orphan/Rare Diseases Solution Award
European Commission approves SPEVIGO® for new and expanded indications in generalized pustular psoriasis
European Commission approves SPEVIGO® for new and expanded indications in generalized pustular psoriasis
European Commission approves SPEVIGO® (spesolimab) for generalized pustular psoriasis flares
European Commission grants marketing authorization for spesolimab, the first specific treatment option for generalized pustular psoriasis flares in adults
Breakthrough Designation granted in US and China
SPEVIGO® granted Breakthrough Therapy Designation in the U.S. for the prevention of generalized pustular psoriasis flares
SPEVIGO®
SPEVIGO® (spesolimab) is a novel, humanized, selective antibody for the treatment of generalized pustular psoriasis (GPP) flares.
U.S. FDA approves first treatment for generalized pustular psoriasis flares in adults
Boehringer Ingelheim announces the U.S. FDA has approved the first treatment for generalized pustular psoriasis (GPP) flares in adults
Spesolimab (BI 655130)
Spesolimab (BI 655130): IL36R antibody
Spesolimab prevents GPP flares
Spesolimab prevents generalized pustular psoriasis flares in EFFISAYIL™ 2 trial
CHMP recommends conditional approval for first GPP treatment
CHMP recommends conditional marketing authorization for novel IL-36 receptor monoclonal antibody, spesolimab, as first treatment for generalized pustular psoriasis flares
Spesolimab meets key endpoint for GPP flare prevention
Spesolimab meets primary and key secondary endpoint for prevention of generalized pustular psoriasis flares