Boehringer Ingelheim’s Spevigo (spesolimab) injection has been recommended by the European Medicines Agency’s human medicines committee for the prevention of generalised pustular psoriasis (GPP).
The Committee for Medicinal Products for Human Use has recommended approval of the injection to prevent GPP flares in adults and adolescents from 12 years, and has also recommended extended approval of Spevigo infusion to treat GPP flares in adults and adolescents from 12 years as a monotherapy.
Recognised as a separate clinical entity from other forms of psoriasis, GPP is a chronic, heterogeneous, neutrophilic inflammatory disease that is associated with skin and systemic symptoms distinct from plaque psoriasis and can sometimes lead to multiple complications, including multisystem organ failure and sepsis.
Already approved in 51 countries, including the EU, US and China, Spevigo is a novel, humanised selective IgG1 antibody that binds to the interleukin-36 receptor, a key part of a signalling pathway within the immune system shown to be associated with GPP.
The Committee for Medicinal Products for Human Use’s decision was based on positive results from the 48-week phase 2b EFFISAYIL 2 clinical trial, as part of the EFFISAYIL clinical programme combining EFFISAYIL 1, a phase 2 study, EFFISAYIL ON, an open-label extension study and the ongoing EFFISAYIL REP open-label, phase 3b/4 trial.
Results from the phase 2b trial showed that Spevigo significantly reduced the risk of GPP flares by 84% in 123 patients compared with placebo and no flare-ups were observed in patients from the high-dose group with Spevigo subcutaneous treatment after week four.
In addition, the trial showed a consistent incidence of patients with adverse events across the Spevigo and placebo treatment arms.
Commenting on the recommendation, Carinne Brouillon, head of human pharma at Boehringer, said: “The CHMP’s positive opinion on Spevigo… signals a strong shift in treatment, offering people living with [GPP] the potential for significant improvement of their condition and a better quality of life.”
Register to receive monthly news alerts and digital magazines