Boehringer Ingelheim has received the US Food and Drug Administration (FDA) approval for its monoclonal antibody, spesolimab, to treat adult patients with generalized pustular psoriasis (GPP) flares.
Spesolimab is a new selective antibody that inhibits the interleukin-36 receptor (IL-36R) signalling activation. It is claimed to be the first treatment option approved to treat GPP flares.
The antibody is said to be the first investigational therapy to specifically target the IL-36 pathway for the GPP flares treatment.
The regulatory approval is based on the data obtained from the pivotal EFFISAYIL 1 Phase II clinical trial conducted in GPP flare patients.
In the study, the participants were randomised in 2:1 ratio and given a single 900mg intravenous dose of spesolimab or placebo.
About 54% of the participants treated with spesolimab demonstrated no visible pustules compared to 6% of the participants treated with placebo, after one week.
At the outset of the trial, most of the participants had a high, or very high, density of pustules, and impaired quality of life.
Boehringer Ingelheim Managing Directors board member Carinne Brouillon said: “This important approval reflects our successful efforts to accelerate our research with the aim to bring innovative treatments faster to the people most in need.
“We recognise how devastating this rare skin disease can be for patients, their families and caregivers.
“GPP can be life-threatening and until today there have been no specific approved therapies for treating the devastating GPP flares.”
Spesolimab has already received Orphan Drug Designation in Switzerland, Korea, Australia, and the US along with Priority Review in the US and China to treat GPP flares.
It has also received Rare Disease Designation and fast track in Taiwan, and Breakthrough Therapy Designation in the US, China, and Taiwan.