More than half of patients treated for psoriasis with an intravenous injection showed no visible pustules just one week after receiving treatment.
Boehringer Ingelheim announced today (September 2) that the U.S. Food and Drug Administration (FDA) has approved the first treatment option, SPEVIGO, 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.
No visible pustules
In the 12-week pivotal Effisayil 1 clinical trial, patients experiencing a GPP flare were treated with SPEVIGO or placebo. After one week, 54% of patients treated with SPEVIGO showed no visible pustules compared to 6% placebo.
During the trial, the most common adverse reactions in under 5% of the patients that received SPEVIGO were asthenia and fatigue, nausea and vomiting, headache, pruritus and prurigo, infusion site hematoma and bruising, and urinary tract infection.
Mark Lebwohl, lead investigator of the trial, said: “GPP flares can greatly impact a patient’s life and lead to serious, life-threatening complications.”
“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.”
Distinct from plaque psoriasis, GPP is a rare and potentially life-threatening neutrophilic skin disease, which is characterized by flares which are episodes of widespread eruptions of painful, sterile pustules.
In the U.S., 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.
Carinne Brouillon, board member responsible for human pharma at Boehringer Ingelheim, said: “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.
“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.”