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LONDON (Alliance News) - GlaxoSmithKline PLC said Wednesday that it has filed regulatory submissions in the US and Europe for mepolizumab as a maintenance treatment for severe eosinophilic asthma.
The submissions include a biologics licence application to the US Food and Drug administration for the drug's use as an add-on maintenance treatment in patients ages 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 adult patients with a history of exacerbations or a dependency on systemic corticosteroids.
"Severe asthma can have serious health consequences and for patients with elevated eosinophil levels whose disease remains uncontrolled despite taking medication, there are few treatment options," said Head of Research and Development at Glaxo's Respiratory Therapy Area Unit Dave Allen in a statement.
"With the regulatory filings announced today, we are taking a further step towards making mepolizumab available for this difficult-to-treat group," Allen added.
Glaxo has planned filings in other countries during 2014 and 2015.
Shares in Glaxo are trading up 0.8% at 1,428.00 pence Wednesday morning.
By Hana Stewart-Smith; hanassmith@alliancenews.com; @HanaSSAllNews
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