GSK EGPA treatment meets endpoints in phase 3 study

GlaxoSmithKline said on Wednesday that both co-primary endpoints and all secondary endpoints were met in a “pivotal” phase III study investigating the efficacy and safety of it smepolizumab treatment in patients with relapsing and refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA).

EGPA is a rare disease characterised by widespread inflammation in the walls of small blood vessels (vasculitis).
A key goal of treatment for EGPA is to induce and maintain remission while reducing the use of corticosteroids and other immunosuppressive therapies, Glaxo said.

The co-primary endpoints for the 52-week study assessed the total duration of remission and the proportion of patients that achieved sustained remission following treatment with mepolizumab compared to treatment with placebo, both on top of standard of care.

Steve Yancey, vice-president and medicine development lead for mepolizumab, GSK said: "We are very pleased to observe the positive benefits of treatment with mepolizumab across several clinically relevant measures in this first ever double-blind, placebo-controlled study in patients with EGPA.”

“Given that patients with this rare systemic inflammatory disease have limited treatment options, these results represent a significant step forward in our efforts to help them. We now look forward to progressing our regulatory submission plans."
Mepolizumab is not approved for use anywhere in the world for EGPA, Glaxo said.

It is approved for use in the EU, under the brand name Nucala, for use as an add-on treatment for severe refractory eosinophilic asthma in adult patients.

Nucala is approved for use in the US as an add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. It is not approved for the treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus, the company added.