Boehringer Ingelheim Earns Breakthrough Therapy Designation for Pustular Psoriasis Drug
The FDA granted breakthrough therapy designation to Boehringer Ingelheim’s Spevigo (spesolimab) as a treatment to prevent flares in adults with generalized pustular psoriasis (GPP).
GPP is a rare and systemic skin disease characterized by flares of painful, sterile pustules eruptions across the body, and can potentially be life-threatening.
The designation was granted based on the results of a Phase 2 clinical trial demonstrating that spesolimab can prevent flares in adolescents and adults with GPP up to 48 weeks.
The breakthrough therapy designation speeds the development and review of a medicine that may offer substantial improvement compared to the available standard of care for the treatment of a serious or life-threatening disease.
About Spevigo (spesolimab)
Spesolimab, sold under the brand name Spevigo, is a monoclonal antibody medication used for the treatment of generalized pustular psoriasis (GPP). It is an interleukin-36 receptor (IL1RL2/IL1RAP) antibody.
It was approved for medical use in the United States in September 2022, and in European Union in December 2022. The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.
May 5, 2023