GSK files for Japanese approval of mepolizumab

UK pharma major GlaxoSmithKline (LSE: GSK) has submitted a regulatory application to the Japanese Ministry of Health, Labor and Welfare (MHLW) for mepolizumab as an add-on maintenance treatment for patients with severe eosinophilic asthma who experience exacerbations on standard treatment.

Mepolizumab is an anti IL-5 monoclonal antibody delivered in a 100mg fixed dose via a subcutaneous injection every four weeks.  GSK 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 last year.

The New Drug Application for mepolizumab has been submitted to the MHLW for adults and adolescents aged 12 years or older 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, and who are treated with high dose ICS and other maintenance treatment(s).