FDA has approved Spevigo (spesolimab) from Boehringer Ingelheim as the first approved treatment option for generalized pustular psoriasis (GPP) flares in adults. Spevigo is a novel, selective antibody that blocks the activation of the interleukin-36 receptor (IL-36R), a key part of a signaling pathway within the immune system shown to be involved in the cause of GPP.

“GPP flares can greatly impact a patient’s life and lead to serious, life-threatening complications,” says Mark Lebwohl, MD, 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 Spevigo 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.”

In the 12-week pivotal Effisayil™ 1 clinical trial, patients experiencing a GPP flare (N=53) were treated with Spevigo or placebo. After one week, patients treated with Spevigo showed no visible pustules (54%) compared to placebo (6%). 

In Effisayil™ 1, the most common adverse reactions (≥5%) in patients that received Spevigo were asthenia and fatigue, nausea and vomiting, headache, pruritus and prurigo, infusion site hematoma and bruising, and urinary tract infection.

Distinct from plaque psoriasis, GPP is a rare and potentially life-threatening neutrophilic skin disease, which is characterized by flares (episodes of widespread eruptions of painful, sterile pustules). In the United States, an estimated 1 out of every 10,000 people has GPP. 

“GPP can have an enormous impact on patients’ physical and emotional wellbeing. With the FDA approval of this new treatment, people living with GPP now have hope in knowing that there is an option to help treat their flares,” says Thomas Seck, MD, Senior Vice President, Medicine and Regulatory Affairs, Boehringer Ingelheim. “Spevigo represents Boehringer Ingelheim’s commitment to delivering meaningful change for patients living with serious diseases with limited treatment options.”