CHMP Recommends Boehringer Ingelheim's Spevigo for Generalised Pustular Psoriasis

Boehringer Ingelheim’s Spevigo (spesolimab) injection has received a recommendation from the European Medicines Agency’s committee for human medicines for a new indication aimed at preventing generalised pustular psoriasis (GPP) flares. This recommendation includes its use in adults and adolescents aged 12 and above. Additionally, the committee has supported extending the approval of Spevigo infusion to treat GPP flares in the same age group as a standalone therapy.

GPP is a distinct clinical condition separate from other types of psoriasis. It is characterized by its chronic, varied, and neutrophilic inflammatory nature, leading to skin and systemic symptoms that are different from those seen in plaque psoriasis. This condition can cause multiple complications, such as multisystem organ failure and sepsis.

Spevigo is currently approved in 51 countries, including major markets like the EU, US, and China. It is a novel, humanized selective IgG1 antibody that specifically binds to the interleukin-36 receptor. This receptor is a critical component of an immune system signaling pathway associated with GPP.

The Committee for Medicinal Products for Human Use (CHMP) based its recommendation on the positive outcomes from the 48-week phase 2b EFFISAYIL 2 clinical trial. This trial is part of the broader EFFISAYIL clinical program, which also includes EFFISAYIL 1, a phase 2 study, EFFISAYIL ON, an open-label extension study, and the ongoing EFFISAYIL REP open-label, phase 3b/4 trial.

The phase 2b trial results indicated that Spevigo significantly reduced the risk of GPP flare-ups by 84% in 123 patients compared to those on a placebo. Furthermore, no flare-ups were observed in patients receiving high-dose Spevigo subcutaneous treatment after week four of the trial. The incidence of adverse events was consistent across both the Spevigo and placebo treatment groups.

Carinne Brouillon, head of human pharma at Boehringer Ingelheim, expressed optimism about the recommendation, stating that CHMP’s positive opinion on Spevigo represents a significant shift in treatment. This recommendation offers individuals living with GPP the potential for considerable improvement in their condition and a better quality of life.

In a related development, Boehringer Ingelheim recently announced the acquisition of Nerio Therapeutics for up to $1.3 billion. This acquisition aims to expand Boehringer’s immune-oncology pipeline by incorporating Nerio’s small molecules, which are designed to inhibit the protein tyrosine phosphatases N1 and N2.

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