The US Food and Drug Administration (FDA) has approved the biologic agent spesolimab (Spevigo) for the treatment of flares in adults with generalized pustular psoriasis (GPP), the company has announced.
"GPP flares can greatly impact a patient's life and lead to serious, life-threatening complications," Mark Lebwohl, MD, principal investigator in the pivotal spesolimab trial, said in a company news release.
"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," said Lebwohl, dean for clinical therapeutics and professor of dermatology, Icahn School of Medicine at Mount Sinai, New York.
Spesolimab is a novel, selective monoclonal antibody that blocks interleukin-36 signaling known to be involved in GPP. It received priority review and had orphan drug and breakthrough therapy designation.
GPP affects an estimated 1 of every 10,000 people in the US.
Though rare, GPP is a potentially life-threatening disease that is distinct from plaque psoriasis. GPP is caused by the accumulation of neutrophils in the skin. Throughout the course of the disease, patients may suffer recurring episodes of widespread eruptions of painful, sterile pustules across all parts of the body.
Spesolimab was evaluated in a global, 12-week, placebo-controlled clinical trial that involved 53 adults experiencing a GPP flare. After 1 week, significantly more patients treated with spesolimab than placebo showed no visible pustules (54% vs 6%), according to the company.
The most common adverse reactions, seen in at least 5% of patients treated with spesolimab, were asthenia and fatigue; nausea and vomiting; headache; pruritus and prurigo; hematoma and bruising at the infusion site; and urinary tract infection.
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Cite this: FDA Okays Spesolimab, First Treatment for Generalized Pustular Psoriasis - Medscape - Sep 02, 2022.