Regulators in U.S. and China Expand Approval for BI’s Spevigo to Include GPP

Rare Daily Staff

The U.S. Food and Drug Administration has approved Boehringer Ingelheim’s Spevigo for the treatment of generalized pustular psoriasis, a rare, chronic, inflammatory disease.

The expanded approval of Spevigo is for adults and pediatric patients aged 12 and above weighing 40 kg or more. The FDA approval follows the Chinese National Medical Products Administration’s approval of Spevigo for the reduction of occurrence of generalized pustular psoriasis (GPP) in adolescents from 12 years of age with a body weight 40 kg or more.

GPP is a chronic, heterogenous, neutrophilic inflammatory disease associated with skin and systemic symptoms that are distinct from plaque psoriasis. GPP is recognized as a separate clinical entity from other forms of psoriasis, with the IL-36 pathway being a key driver of GPP and triggering response to treatment. The condition can become life-threatening due to severe complications, such as multisystem organ failure and sepsis requiring urgent hospital care. Many people with GPP also suffer from various comorbidities, which contribute to the ongoing burden for the patient and healthcare systems.

Spevigo is a novel, humanized selective IgG1 antibody that binds to interleukin-36 receptor, a key part of a signaling pathway within the immune system shown to be involved in the cause of GPP.

The approvals are based, in part, on the positive results of the EFFISAYIL 2 clinical trial, a 48-week study that showed that Spevigo reduced the risk of GPP flares by 84 percent compared with placebo. In the trial with 123 patients, no flares were observed after week 4 of Spevigo subcutaneous treatment in the high-dose group.

In the Effisayil 2 trial, Spevigo was associated with an increased incidence of injection site reaction, urinary tract infection, arthralgia, and pruritus compared to placebo.

“Until now, people living with GPP have not had any approved options to treat their disease,” said Bruce Strober, clinical professor of dermatology at Yale University and Central Connecticut Dermatology. “Spevigo has the potential to redefine the treatment options for the patients we serve.”

Photo: Bruce Strober, clinical professor of dermatology at Yale University and Central Connecticut Dermatology