Boehringer Ingelheim Spesolimab bags USFDA Breakthrough Therapy Designation for prevention of generalized pustular psoriasis flares
Generalized pustular psoriasis is a rare and potentially life-threatening chronic neutrophilic skin disease characterized by flares of widespread eruptions of painful, sterile pustules across the body.
Ingelheim: Boehringer Ingelheim has announced that spesolimab (marketed as SPEVIGO) has received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) as an investigational treatment for the prevention of flares in adolescents and adults with generalized pustular psoriasis (GPP).
“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. 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.
Spesolimab is a novel, humanized, selective antibody that blocks the activation of the interleukin-36 receptor (IL-36R), a signaling pathway within the immune system shown to be involved in the pathogenesis of several autoinflammatory diseases, including GPP. Spesolimab has been approved by regulatory authorities in almost 40 countries including the US, Japan, Mainland China, and the European Union to treat GPP flares in adults.
