Spevigo® is the commercial brand name of Spesolimab Injection, a humanized selective monoclonal antibody targeting IL‑36 receptor developed by Boehringer Ingelheim. It blocks the activation of IL‑36R and inhibits downstream inflammatory cascades to control flares of generalized pustular psoriasis.
Main Indications
Treatment of flares of generalized pustular psoriasis in adult patients;
Treatment of flares of generalized pustular psoriasis in adolescents aged 12 years and above.
Clinical Research
Global multicenter phase III pivotal trials demonstrated that spesolimab rapidly achieves clinical resolution of pustules and improves skin symptoms during acute flares of generalized pustular psoriasis;
Clinical trials including Chinese patients confirmed rapid onset of action and consistent efficacy and safety outcomes compared with global study populations;
Long-term follow-up studies verified sustained disease control for recurrent attacks and a predictable safety profile during repeated administration.
Common Side Effects
Severe but important risks: Serious infections, severe hypersensitivity reactions, hepatic adverse events;
Common mild adverse reactions: Fatigue, pruritus, headache, arthralgia, diarrhoea and injection-related reactions.
Approval Status in China
Original drug Spevigo® (Spesolimab Injection) was officially approved for marketing in China in 2022, with the specification of 450mg/7.5mL per vial. It is a prescription biologic agent.
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