EC grants conditional marketing authorization based on the EFFISAYIL 1 trial, which demonstrated that over half of the spesolimab-treated patients were free of pustules, one week after receiving a single dose1,2
Generalized pustular psoriasis (GPP) differs significantly from plaque psoriasis in both its disease mechanism and severity2,3,4
The EMA’s decision builds on existing approvals in the USA and Japan5
INGELHEIM, Germany -- (BUSINESS WIRE) --
The European Commission (EC) granted a conditional marketing authorization for Boehringer Ingelheim’s spesolimab as first in class treatment for GPP flares in adults.1 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.2, 4-7
“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.2 In the 12-week trial, patients experiencing a GPP flare were treated with spesolimab or placebo. Most patients at the outset of the trial had a moderate or severe pustulation of the skin. After one week, 54% of patients treated with a single dose of spesolimab showed no visible pustules compared to placebo (6%).2 Adverse events were reported in 66% of patients treated with spesolimab and 56% of those receiving placebo after one week.2 Infections were reported by 17% and 6% of patients in the spesolimab and placebo groups respectively (at week one).2 Serious adverse events were reported in 6% of patients treated with spesolimab (at week one).2
People living with GPP often do not receive a correct or timely diagnosis and may have their symptoms identified as other forms of psoriasis. A Global Delphi Consensus Project classified GPP as phenotypically, genetically, immunologically and histopathologically distinct from psoriasis vulgaris / plaque psoriasis based on a systematic literature review.3 The growing list of regulatory approvals for spesolimab for the treatment of GPP flares underlines that the Delphi panel’s vision of improved diagnosis and treatment for people with GPP is increasingly achievable.
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Press release
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