Nucala (mepolizumab) filed with FDA as an add-on therapy to corticosteroids for the treatment of adult patients with Eosinophilic Granulomatosis with Polyangiitis- GlaxoSmithKline

GlaxoSmithKline announced the submission of a supplemental Biologics License Application (sBLA) to the United States Food and Drug Administration (FDA), seeking approval of Nucala (mepolizumab), an interleukin-5 (IL-5) antagonist, as an add-on therapy to corticosteroids for the treatment of adult patients with Eosinophilic Granulomatosis with Polyangiitis (EGPA).

The regulatory submission is based on results from a pivotal, 52-week Phase III study which evaluated the efficacy and safety of mepolizumab vs placebo as an add-on therapy to standard of care in patients with relapsing and/or refractory EGPA. Regulatory filings in other countries are planned during the course of 2017 and 2018. Mepolizumab is not approved anywhere in the world for EGPA.