GlaxoSmithKline and Theravance announced Thursday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval for Relvar Ellipta (fluticasone furoate/vilanterol). The companies applied to have the inhaled once-daily drug cleared as a treatment 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 positive opinion was supported by the findings of 11 clinical studies in 7851 patients with COPD and 16 studies in 9326 patients with asthma. The company proposed two doses of the therapy for the asthma indication and a single dose level for COPD. The therapy is administered using GlaxoSmithKline's Ellipta dry powder inhaler. Patrick Vallance, GlaxoSmithKline's president of pharmaceuticals R&D, said that "what is particularly exciting is that we have achieved the first of what we hope…could be many positive regulatory outcomes supporting the potential use of [this therapy] in appropriate patients with asthma." A final decision by the European Commission is expected in the fourth quarter of this year.
The recommendation by the CHMP follows the FDA approval of the therapy in May under the trade name Breo Ellipta as a treatment for COPD. However, the companies withdrew their Japanese application for the treatment in the COPD indication, while the drug's filing as an asthma therapy remains under review in the country.
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.
Earlier this month, an FDA advisory panel recommended approval of GlaxoSmithKline and Theravance's COPD therapy Anoro Ellipta (umeclidinium/vilanterol), which combines a LABA with a long-acting muscarinic antagonist. The treatment remains under review in Europe and Japan (for related analysis of Anoro, read In Focus: GlaxoSmithKline's Anoro – can physicians be convinced sufficiently to drive drug towards blockbuster aspirations and FirstWord Physician Views: Can GlaxoSmithKline strike early with Anoro? / What role will dosing, inhaler type play in uptake of LAMA/LABA combinations for COPD?).
To read more Top Story articles, click here.