The European Commission (EC) granted a conditional marketing authorization for Boehringer Ingelheim’s spesolimab as first in class treatment for GPP flares in adults. Spesolimab is a novel, 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 GPP.

“The symptoms of GPP are devastating and cause immense pain as well as hospitalization during a flare. Increased GPP awareness that leads to accurate and faster diagnosis is one important step to improving the quality of life for people living with GPP,” said Frida Dunger Johnsson, Executive Director, IFPA. “Now with a specifically developed treatment, people living with GPP can be offered a new lease of life by effectively managing the impact of GPP flares.”

“We are delighted to be able to bring this much needed treatment to patients with GPP, whose options were incredibly limited until this year. This approval marks another significant milestone in the continued development of spesolimab in neutrophilic skin diseases which we are investigating in further clinical trials” commented Carinne Brouillon, Member of the Board of Managing Directors, responsible for Human Pharma, Boehringer Ingelheim. “Today’s news marks the first of what we hope will be a number of new treatment options from our accelerated late-stage portfolio with the potential to transform the lives of people for generations to come.”

The EC’s conditional approval of spesolimab is based on results from the pivotal EFFISAYIL 1 Phase II clinical trial. In the 12-week trial, patients experiencing a GPP flare were treated with spesolimab or placebo.