GlaxoSmithKline – Hypereosinophilic Syndrome

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The market authorisation application for mepolizumab for the indication of hypereosinophilic
syndrome (HES) was filed in 2008, but later the file was withdrawn due to outstanding
questions from regulator’s raised from the application. On the basis of sponsor’s
evaluation, participants with life-threatening HES who have documented failure (lack of
efficacy or a contra-indication) to at least 3 standard HES therapies (compassionate use)
and participants who have participated in a previous GSK sponsored study in HES (long-term
access) can be consider for mepolizumab treatment where the country regulation permits. In
this study, participants will receive mepolizumab in an open-labelled manner, and limited
data will be collected to evaluate the long-term safety and efficacy of mepolizumab.