GlaxoSmithKline files for US and EU approval of mepolizumab

5 November 2014

UK pharma major GlaxoSmithKline (LSE: GSK) says it has filed regulatory submissions in the USA and Europe for mepolizumab (proposed trade name Bosatria) for approval as a maintenance treatment for patients with severe eosinophilic asthma, identified by a blood eosinophil count of at least 150 cells per microlitre at the start of treatment or 300 cells per microlitre in the past 12 months.

The submissions comprise:

a Biologics Licence Application to the US Food and Drug Administrationas an add-on maintenance treatment for severe eosinophilic asthma in patients aged 12 years and older with a history of exacerbations; and
a Marketing Authorization Application to the European Medicines Agency as an add-on treatment for severe eosinophilic asthma in adult patients with a history of exacerbations and/or dependency on systemic corticosteroids.

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