Boehringer Ingelheim has received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for spesolimab (SPEVIGO) to prevent generalised pustular psoriasis (GPP) flares.
The antibody received the designation as an investigational treatment to prevent flares in adolescents and adults.
The Center for Drug Evaluation of China’s National Medical Products Administration has also awarded a BTD to spesolimab.
Boehringer Ingelheim managing directors board member and human pharma head Carinne Brouillon stated: “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.
“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.”
Both designations were granted based on topline data from the EFFISAYIL 2 trial that examined whether long-term treatment with spesolimab helps to prevent the flares in adolescents as well as adults with GPP for up to 48 weeks.
Safety data were found to be consistent with earlier clinical trials.
Spesolimab is a humanised selective antibody that blocks interleukin-36 receptor (IL-36R) activation.
It has now gained approval from regulatory authorities in 40 countries, including Japan, the US and mainland China, as well as the European Union.
In April 2023, Boehringer Ingelheim and Swiss company RetinAI Medical collaborated to leverage artificial intelligence to advance novel treatments for geographic atrophy patients.