Boehringer Ingelheim’s Spevigo gains additional approvals in US and China
Betsy Goodfellow | March 20, 2024 | News story | Medical Communications | Boehringer Ingelheim, Dermatology, FDA, Spevigo, psoriasis
Boehringer Ingelheim has announced that Spevigo (spesolimab-sbzo) has been approved by the US Food and Drug Administration (FDA) for the treatment of generalised pustular psoriasis (GPP) in adult and paediatric patients over the age of 12 and weighing ≥40kg.
This FDA approval follows the Chinese National Medical Products Administration’s (NMPA) approval of the drug for the reduction of occurrence of GPP in adults and adolescents from 12 years of age and a body weight of ≥40kg.
Both approvals are predominantly based on results from the EFFISAYIL 2 trial, a 48-week trial which demonstrated that the drug significantly reduced risk of GPP flares by 84%, compared to placebo. The trial included 123 patients, with no flares being observed after week four of subcutaneous treatment with Spevigo in the high dose group.
However, the drug was associated with an increased risk of injection site reaction, urinary tract infection, arthralgia and pruritis compared to placebo.
Carinne Brouillon, member of the board of managing directors and head of Human Pharma at Boehringer Ingelheim, commented: “Spevigo’s new approvals constitute a fundamental change for people living with GPP, addressing their huge need for acute and chronic treatment. 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.”
Betsy Goodfellow
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