GSK seeks approval for asthma drug mepolizumab in US and Europe

Mepolizumab is delivered in a 100mg dose via subcutaneous injection every four weeks.

Eosinophilic asthma is 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.

The company has submitted a Biologics Licence Application (BLA) of mepolizumab to the US Food and Drug Administration (FDA) as an add-on maintenance treatment for severe eosinophilic asthma in patients aged 12 years and older with a history of exacerbations.

The European Medicines Agency (EMA) has also received a marketing authorization application (MAA) for the drug to be used as an add-on treatment for severe eosinophilic asthma in adult patients with a history of exacerbations and/or dependency on systemic corticosteroids.

The submissions of BLA and MAA are based on data from the Phase III MENSA and SIRIUS studies as well as the Phase IIb/III DREAM trial.

The two trials MENSA and SIRIUS evaluated 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.

GSK head of Respiratory Therapy Area Unit, R&D 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.

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

The company intends to submit additional regulatory filings in other countries during the course of 2014 and 2015.

Currently, mepolizumab is not approved for use anywhere in the world.