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.

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