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news.GlaxoSmithKline (GSK) has submitted a new drug application (NDA) to the Japanese Ministry of Health, Labour and Welfare (MHLW) seeking approval for mepolizumab, an anti IL-5 monoclonal antibody, as an add-on maintenance treatment for patients with severe eosinophilic asthma who experience exacerbations on standard treatment.
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Mepolizumab is delivered in a 100mg fixed dose via a subcutaneous injection every four weeks.
The NDA for mepolizumab is for adults and adolescents aged 12 years or older, and who are treated with high dose ICS and other maintenance treatment(s).
The drug is indicated for adults and adolescents 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.
Currently, mepolizumab is not approved for use anywhere in the world and regulatory filings in a number of other countries, including the US and EU, are underway.
The company said that further submissions are planned during the course of this year.
In severe eosinophilic asthma, over-production of eosinophils (a type of white blood cell) cause inflammation in the lungs that can affect the airways, limiting breathing and increasing the frequency of exacerbations.
Currently, mepolizumab is also being evaluated in eosinophilic chronic obstructive pulmonary disease (COPD) and Eosinophilic Granulomatosis with Polyangiitis (EGPA).
Image: GlaxoSmithKline (GSK) headquaters in London, UK. Photo: courtesy of Maxwell Hamilton.