German giant Boehringer Ingelheim announced receiving marketing approval from the National Medical Products Administration (NMPA) for its Spevigo (spesolimab) to treat generalized pustular psoriasis (GPP) in adults. Notably, the drug, previously awarded breakthrough therapy and priority review statuses in China, took a mere three months after gaining approval in the United States to arrive in China.
Mechanism of Action and Clinical Trial Results
The selective IgG1 monoclonal antibody (mAb) can block the activation of interleukin-36 receptor (IL-36R), a signal pathway in the immune system related to the pathogenesis of many autoimmune diseases such as GPP. The global, multicenter, double-blind, randomized controlled Phase II Effisagil 1 study has shown that 54.3% of patients have no visible pustules in their skin after one week of treatment with Spevigo. A total of 42.9% of patients can achieve the elimination or near-elimination of skin symptoms after one week of treatment with Spevigo, while the product has a good safety profile. Common adverse events include fever and mild to moderate infection.
Development and Future Indications
At present, the drug is also being developed as a maintenance treatment for GPP and to treat other neutrophilic skin diseases, positioning Spevigo as a potential therapeutic option for a broader range of autoimmune conditions.-Fineline Info & Tech
