INGELHEIM, GERMANY-- September 02, 2022 -- The U.S. Food and Drug Administration is the first regulatory authority to approve spesolimab as a treatment option for generalized pustular psoriasis (GPP) flares in adults, Boehringer Ingelheim announced today. Spesolimab, marketed in the U.S. as SPEVIGO®, 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.

“GPP flares can greatly impact a patient’s life and lead to serious, life-threatening complications,” said Mark Lebwohl, M.D., lead investigator and publication author, and Dean for Clinical Therapeutics, Icahn School of Medicine at Mount Sinai, Kimberly and Eric J. Waldman Department of Dermatology, New York. “The approval of spesolimab is a turning point for dermatologists and clinicians. We now have an FDA-approved treatment that may help make a difference for our patients who, until now, have not had any approved options to help manage GPP flares.”

“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,” said Carinne Brouillon, Member of the Board of Managing Directors, responsible for Human Pharma, Boehringer Ingelheim. “We recognize 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. It makes me proud that with the approval of SPEVIGO® we can now offer the first U.S. approved treatment option for those in need.”

The FDA’s approval of spesolimab is based on results from the pivotal EFFISAYIL® 1 Phase II clinical trial.1 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 high, or very high, density of pustules, and impaired quality of life. After one week, 54% of patients treated with spesolimab showed no visible pustules compared to placebo (6%).1

In addition to the U.S. approval, spesolimab is currently under review by several other regulatory authorities. To date, spesolimab has received Breakthrough Therapy Designation in the U.S., China and Taiwan, Priority Review in the U.S. and China, Orphan Drug Designation in the U.S., Korea, Switzerland and Australia, Rare Disease Designation and fast track in Taiwan, for the treatment of GPP flares. The European Medicines Agency validated the marketing authorization application for spesolimab in GPP in October 2021 and the submission is currently under evaluation.

Distinct from plaque psoriasis, GPP is a rare and potentially life-threatening neutrophilic skin disease, characterized by episodes of widespread eruptions of painful, sterile pustules. Given that it is so rare, recognizing the symptoms can be challenging and consequently lead to delays in diagnosis.