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A group of FDA advisers backed GlaxoSmithKline's latest asthma treatment for use in adults but balked at recommending it for adolescents, setting the stage for a likely approval in the fall.
Via Krishan Maggon
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Rescooped by Gilbert C FAURE from Top Selling Monoclonal Antibodies |
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Via Krishan Maggon
The BLA for mepolizumabwas submitted to the FDA in November 2014 for approval as an add-on maintenance treatment for patients with severe asthma with eosinophilic inflammation, 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.
Mepolizumab is an investigational monoclonal antibody, which stops IL-5 from binding to its receptor on the surface of eosinophils. Inhibiting IL-5 binding in this way reduces blood, tissue and sputum eosinophil levels.