Germany-based Boehringer Ingelheim’s (BI) interleukin-36 receptor (IL-36R)-targeted orphan drug, Spevigo (spesolimab), in subcutaneous injection form, is poised for priority review status in China. This recognition from the Center for Drug Evaluation (CDE) is attributed to its potential use in preventing flares in generalized pustular psoriasis (GPP), following the molecule’s earlier breakthrough therapy designation.
Spevigo’s Impact on GPP Treatment
Spevigo was first approved in China in December of the previous year for the treatment of GPP flare-ups. GPP is a rare and severe skin disease characterized by extensive blistering on the skin, which can lead to organ failure and even death, unlike plaque psoriasis. The initial approval was for a single intravenous injection of spesolimab at a dose of 900mg over more than 90 minutes.
The Significance of Priority Review Status
The potential priority review status for Spevigo underscores the drug’s importance in addressing the unmet medical needs of GPP patients. This designation could expedite the drug’s regulatory process, making it more rapidly available to patients suffering from this debilitating condition.-Fineline Info & Tech
