Bosatria filed with FDA and EMA for Eosinophilic Asthma-GSK

GlaxoSmithKline announced that it has filed regulatory submissions in the USA and Europe for Bosatria (mepolizumab) 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 Authorisation 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.

The regulatory submissions in the USA and Europe are based on studies of patients with severe asthma and include the Phase III MENSA and SIRIUS studies published in the New England Journal of Medicine in September 2014 as well as the earlier Phase IIb/III DREAM study published in the Lancet in 2012. Both the MENSA and SIRIUS studies evaluated patients with blood eosinophils of either 150 or more cells per microlitre at initiation of treatment or 300 or more cells per microlitre in the previous 12 months.