US regulatory submission for mepolizumab as EGPA treatment

29 June 2017

UK pharma major GlaxoSmithKline (LSE: GSK) has filed for US approval for an expanded indication of its an interleukin-5 (IL-5) antagonist for the treatment of a rare disease.

The company has submitted supplemental Biologics License Application (sBLA) to the US Food and Drug Administration seeking approval of mepolizumab as an add-on therapy to corticosteroids for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).

EGPA is a rare disease, characterized by widespread inflammation in the walls of small blood vessels (vasculitis) which may lead to tissue and organ damage. The disease may affect multiple organ systems and be associated with symptoms of fatigue, muscle and joint pain and weight loss.

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