FDA Approves Boehringer’s Spevigo, First Treatment for Generalized Pustular Psoriasis Flares in Adults

The U.S. Food and Drug Administration has approved Boehringer Ingelheim’s Spevigo, the first approved treatment option for generalized pustular psoriasis flares in adults.

Photo: Thomas Seck, senior vice president, Medicine and Regulatory Affairs, Boehringer Ingelheim

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, it is estimated that 1 out of every 10,000 people has GPP. Given that it is so rare, recognizing the signs and symptoms can be challenging and consequently lead to delays in diagnosis.

GPP is caused by neutrophils (a type of white blood cell) accumulating in the skin, resulting in painful, sterile pustules all over the body. The clinical course varies, with some patients having a relapsing disease with recurrent flares, and others having a persistent disease with intermittent flares. While the severity of GPP flares can vary, if left untreated they can be life-threatening due to complications such as sepsis and multisystem organ failure. GPP flares can lead to hospitalization with serious complications, including heart failure, renal failure and sepsis, and the unpredictability and severity of these flares greatly affect a person’s quality of life.

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 causing generalized pustular psoriasis (GPP).

“GPP flares can greatly impact a patient’s life and lead to serious, life-threatening complications,” said Mark Lebwohl, lead investigator and dean for Clinical Therapeutics, Icahn School of Medicine at Mount Sinai, Kimberly and Eric J. Waldman Department of Dermatology in 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.”

Approval was based on the 12-week pivotal Effisayil 1 clinical trial, in which patients experiencing a GPP flare were treated with Spevigo or placebo. After one week, patients treated with Spevigo showed no visible pustules (54 percent) compared to placebo (6 percent).

The most common adverse reactions (≥5 percent) 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.

“GPP can have an enormous impact on patients’ physical and emotional wellbeing,” said Thomas Seck, senior vice president, Medicine and Regulatory Affairs, Boehringer Ingelheim. “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.”

Author: Rare Daily Staff