Spevigo approved to treat adolescents with generalized pustular psoriasis in US, China
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Key takeaways:
- The FDA expanded Spevigo’s approval to include children aged 12 years and older weighing 40 kg or more.
- The Chinese National Medical Products Administration also approved Spevigo.
The FDA has approved an expanded indication for Spevigo injection to treat generalized pustular psoriasis in pediatric patients aged 12 years and older weighing 40 kg or more, Boehringer Ingelheim announced in a press release.
As Healio previously reported, Spevigo (spesolimab) was first approved for generalized pustular psoriasis (GPP) in adults in September 2022, making it the first investigational drug to target the interleukin-36 pathway for GPP flares. Today, the expanded indication brings Spevigo to children aged 12 years and older making it the first targeted therapy that addresses the need for acute and chronic treatment for GPP.
“Spevigo’s new approvals constitute a fundamental change for people living with GPP, addressing their huge need for acute and chronic treatment,” Carinne Brouillon, PharmD, MBA, a member of the board of managing directors and head of human pharma at Boehringer Ingelheim, said in the release. “Experiencing GPP can be mentally and physically devastating, leaving those affected with uncertainty and fear of the next episode. Therefore, expanding the treatment of GPP is a critical step towards addressing patients’ needs.”
This approval also follows the Chinese National Medical Products Administration’s recent approval of Spevigo for the reduction of occurrence of GPP in the same adolescent indication.
According to the release, these approvals were based on positive results from Effisayil 2, a 48-week clinical trial that showed a significant 84% reduction in the risk for GPP flares in those treated with Spevigo vs. placebo. By week 4, the high-dose Spevigo injection group did not experience any GPP flares.
Safety data showed that Spevigo exhibited an increased incidence of injection site reaction, urinary tract infection, arthralgia and pruritus vs. placebo.
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