EU clears GlaxoSmithKline, Theravance's Relvar Ellipta for COPD and asthma

GlaxoSmithKline and Theravance reported Monday that the European Commission approved Relvar Ellipta (fluticasone furoate/vilanterol) for adults with chronic obstructive pulmonary disease (COPD), as well as for people aged 12 and over whose asthma is inadequately controlled with inhaled corticosteroids (ICS) and as-needed inhaled short-acting beta agonists. The decision follows a positive opinion issued in September by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) regarding use of the inhaled once-daily drug for these indications.

The approval of Relvar in Europe was supported by findings from 10 clinical studies in 7783 patients with COPD and 16 studies in 9326 patients with asthma. The companies noted that the drug was approved at two dose strengths for asthma and at a single dose level for COPD. Both strengths will be administered once-daily using the Ellipta dry powder inhaler.

"This [approval] is yet another important achievement and is testament to our successful partnership with [GlaxoSmithKline] in respiratory disease," said Theravance CEO. Rick E Winningham. Under the terms of the 2002 agreement between the drugmakers, GlaxoSmithKline will make a milestone payment of $15 million to Theravance for the approval of Relvar in Europe and will make a second payment of $15 million to Theravance upon the EU launch of the drug.

The FDA approved the therapy for the treatment of COPD under the name Breo Ellipta in May. Relvar Ellipta received clearance in Japan in September as a treatment for bronchial asthma while in July, GlaxoSmithKline and Theravance withdrew their Japanese application for the treatment of COPD.

For related analysis of Relvar and other long-acting beta agonist (LABA)/ICS combinations, read Physician Views Poll Results – European pulmonologists appear less receptive to once-daily LABA/ICS therapies than US counterparts for COPD and ViewPoints: Nearly a quarter of European patients struggle to comply with twice-daily dosing when treated with LABA/ICS combination therapies.

Also see FirstWord Therapy Trends – COPD: Combinations therapies to drive significant market growth.

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