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November 5, 2014

GSK seeks regulatory approvals for eosinophilic asthma drug in US and Europe

British drug-maker GlaxoSmithKline (GSK) has submitted regulatory applications in the US and Europe for approval of its mepolizumab to treat patients with severe eosinophilic asthma.

GSK

British drug-maker GlaxoSmithKline (GSK) has submitted regulatory applications in the US and Europe for approval of its to treat patients with severe eosinophilic asthma.

Mepolizumab is an investigational humanised IgG1 monoclonal antibody specific for IL-5. It binds to IL-5 and prevents it from binding to its receptor on the surface of eosinophils.

The submissions include a biologics application to US Food and Drug Administration (FDA) as an add-on maintenance treatment for severe eosinophilic asthma in patients aged over the age of 12 with a history of exacerbations.

The company has submitted a marketing authorisation application to the European Medicines Agency (EMA) as an add-on treatment for severe eosinophilic asthma in adult patients with a history of exacerbations and dependency on systemic corticosteroids.

GSK respiratory therapy area unit head Dave Allen said: "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.

"Submissions were based on the Phase III Mensa and Sirius studies in September, as well as the earlier Phase IIb/III Dreamstudy in 2012."

"With the regulatory filings announced today, we are taking a further step towards making mepolizumab available for this difficult-to-treat group."

The drug is delivered in a 100mg dose through subcutaneous injection every four weeks, said GSK.

Submissions were based on the Phase III Mensa and Sirius studies in September, as well as the earlier Phase IIb/III Dreamstudy in 2012.

Mensa and Sirius trials assessed 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.

The company is also planning to file regulatory applications for mepolizumab in other countries during 2014 and 2015, as it is not currently approved for use in any part of the world.


Image: GlaxoSmithKline (GSK) headquarters in Brentford, London, England. Photo: courtesy of Maxwell Hamilton.

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