GlaxoSmithKline files for EU approval of extended Relvar Ellipta use

GlaxoSmithKline has applied for European approval of its asthma drug Relvar Ellipta in an expanded indication.

In collaboration with Innoviva, the company has filed a submission with the European Medicines Agency for the extended use of the once-daily inhaled corticosteroid/long-acting beta 2 agonist combination in patients already adequately controlled with a treatment in the same class.

The current indication for Relvar Ellipta in Europe allows the drug to be used in the regular treatment of patients aged 12 and over with asthma who are not adequately controlled on both inhaled corticosteroids and short-acting beta 2 agonists.

This new filing is based on the results of a recent lung function study showing that patients with well-controlled asthma can switch to using Relvar Ellipta without compromising their lung function.

Currently, more than half of asthma patients continue to experience poor control and significant symptoms impacting their daily life, despite recent medical advances. As such, GlaxoSmithKline is keen to expand the availability of innovative new therapies.

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