German pharmaceutical giant Boehringer Ingelheim (BI) has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its biologic drug Spevigo (spesolimab) subcutaneous injection. The drug is indicated for reducing the incidence of generalized pustular psoriasis (GPP) in adolescents aged 12 and above weighing at least 40kg, as well as adults.
The approval of Spevigo’s subcutaneous formulation in China follows the global multi-center, pivotal EFFISAYIL 2 study, which assessed the drug’s efficacy and safety as a maintenance therapy. The study aimed to reduce GPP episodes and continuously control GPP symptoms in the target demographic. Clinical data indicated that, compared to a placebo, spesolimab significantly lowered the risk of GPP attacks by 84% over a period of up to 48 weeks. The trial involved 123 patients and showed that no GPP episodes occurred in the high-dose group after 4 weeks of treatment.
Spesolimab injection was previously approved in China to treat GPP attacks in December 2022. Boehringer Ingelheim’s first-in-class monoclonal antibody (mAB) works by blocking the interleukin-36 receptor (IL-36R), which plays a role in signal transduction for various inflammatory diseases.- Flcube.com
