Ingelheim, Germany:
- Based on results from the EFFISAYIL™ 2 trial, which met its primary and key secondary endpoints for the prevention of generalized pustular psoriasis (GPP) flares1,2,3
- Designation granted in recognition of the severe physical and mental health impact of flares in this unpredictable chronic skin disease
- Breakthrough Therapy Designation is a testimony of Boehringer Ingelheim’s pipeline acceleration and the ambition to create value in areas of unmet medical need
Boehringer Ingelheim announced today that spesolimab (marketed as SPEVIGO®) received Breakthrough Therapy Designation (BTD) as an investigational treatment for the prevention of flares in adolescents and adults with generalized pustular psoriasis (GPP) from the U.S. Food and Drug Administration (FDA).
“GPP flares may appear suddenly, intensify quickly, and can be life-threatening if left untreated, leaving those affected feeling anxious and uncertain about their future” said Carinne Brouillon, Member of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim. “The FDA’s recognition of the urgent need for preventing GPP flares is a major step towards empowering people living with the condition to plan critical moments in their lives, despite their disease.”
This designation follows the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA), who also recently awarded spesolimab a BTD for the prevention of GPP flares.
The U.S. FDA and China’s NMPA granted these designations based on the topline results from the EFFISAYIL™ 2 trial which studied whether long-term treatment with the antibody spesolimab helps prevent GPP flares in adolescents and adults with GPP up to 48 weeks.1,2,3 Safety data were in line with previously conducted clinical trials with spesolimab. Data from the trial will be presented at the 25th World Congress of Dermatology 2023 in early July.
