Boehringer Ingelheim announced that the US Food and Drug Administration (FDA) has approved Spevigo (spesolimab) to treat generalised pustular psoriasis (GPP) flares in adults.

Spevigo is a novel, selective monoclonal antibody that works by inhibiting the activation of the interleukin-36 receptor (IL-36R).

IL-36R is a signalling pathway within the immune system, believed to be responsible for the pathogenesis of GPP.

It is the first regulatory approval for the drug, and is currently being reviewed by regulatory authorities in various other countries, said the German pharmaceutical company.

Boehringer Ingelheim board of managing directors member Carinne Brouillon 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.”

The FDA approval is based on positive data from the Phase 2 EFFISAYIL trial, which evaluated Spevigo in patients experiencing a GPP flare, compared to placebo.

At the outset of the clinical study, the majority of patients had a high, or very high density of pustules, and impaired quality of life.

After one week, 54% of patients treated with Spevigo experienced no visible pustules compared to placebo, said Boehringer Ingelheim.

GPP is a rare and potentially life-threatening neutrophilic skin disease, characterised by episodes of widespread eruptions of painful, sterile pustules.

Lead investigator and publication author Mark Lebwohl said: “GPP flares can greatly impact a patient’s life and lead to serious, life-threatening complications.

“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.”

Prior to the FDA approval, the drug has been granted Breakthrough Therapy Designation, Priority Review, Orphan Drug Designation, Rare Disease and fast track designation in several countries.

The European Medicines Agency validated the company’s marketing authorisation application for Spevigo in October last year and is currently under evaluation.