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Boehringer Ingelheim Earns Breakthrough Therapy Designation for Pustular Psoriasis Drug

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


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