Relvar Ellipta Supported by EMA Advisors

Advisors to the European Medicines Agency (EMA) have voted in support of approving GlaxoSmithKline/ Theravance’s Relvar Ellipta for both asthma and chronic obstructive pulmonary disease (COPD).

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has delivered a response recommending marketing authorisation for Relvar Ellipta, a combination of the inhaled corticosteroid fluticasone furoate and the long-acting beta2 agonist vilanterol, delivered through the Ellipta inhaler.  Relvar Ellipta had previously been approved in the USA in May this year for COPD, where it will be sold as Breo Ellipta.

Within the assessment, the European regulatory agency reviewed results from 11 different clinical studies involving 7,851 patients with COPD, and 16 clinical trials involving 9,326 asthma patients.  A final decision by the European Commission is anticipated during the fourth quarter.

GlaxoSmithKline’s president of pharmaceuticals R&D, Patrick Vallance, commented that GSK have been developing these molecules as a potential new combination treatment for over ten years.

Vallance added that “what is particularly exciting is that we have achieved the first of what we hope in the future could be many positive regulatory outcomes supporting the potential use of [Relvar] in appropriate patients with asthma.”

The recommendation is additional positive news for GlaxoSmithKline (GSK) and Theravance, as it comes roughly a week after advisors to the US Food and Drug Administration (FDA) recommended approval of Anoro Ellipta, which combines the long-acting muscarinic antagonist (LAMA) umeclidinium bromide with vilanterol.


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