Boehringer Ingelheim announced that the U.S. FDA granted breakthrough therapy designation for spesolimab as an investigational treatment for the prevention of flares in adults with generalized pustular psoriasis (GPP).

GPP is a rare and potentially life-threatening chronic neutrophilic skin disease characterized by flares of widespread eruptions of painful, sterile pustules across the body. Flares greatly affect a person’s quality of life and can lead to hospitalization with serious complications, including heart failure, renal failure, sepsis, and death.

“GPP flares can appear suddenly and intensify quickly, often leaving patients with a heavy emotional burden,” said Claudia Beqaj, executive director, dermatology, sales, and marketing, Boehringer Ingelheim. “The FDA’s action reinforces the potential of spesolimab and represents a critical step in bringing this treatment to patients who need it most. We look forward to working with the FDA to accelerate the development of this treatment.”

The FDA’s Breakthrough Therapy designation is intended to expedite the development and review of a medicine that is intended to treat a serious or life-threatening disease and preliminary clinical evidence indicates the drug may demonstrate substantial improvement over available treatments.

Spesolimab is marketed as SPEVIGO (spesolimab-sbzo) injection, for intravenous use by Boehringer Ingelheim.

Spesolimab is being investigated for use in additional GPP settings.