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Home Industry News GlaxoSmithKline receives backing for new EU approval of Relvar Ellipta

GlaxoSmithKline receives backing for new EU approval of Relvar Ellipta

30th January 2018

GlaxoSmithKline has announced that its asthma therapy Relvar Ellipta has been recommended for an expanded indication in the EU.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending a label update for the use of once-daily Relvar Ellipta in patients whose asthma is already adequately controlled on both an inhaled corticosteroid and long-acting beta 2-agonist.

In clinical trials, it was demonstrated that patients with adequately controlled asthma were able to switch to Relvar Ellipta delivered via the Seretide Accuhaler without compromising their lung function.

Following this CHMP recommendation, a final approval decision from the European Commission is anticipated towards the end of the first quarter of 2018.

Jonathan Sweeting, senior vice-president and global head of GlaxoSmithKline's respiratory franchise, said: "We are very excited about achieving this CHMP positive opinion which, if approved, provides an additional option for physicians, who can prescribe once-daily Relvar Ellipta for their asthma patients."

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