GlaxoSmithKline, Theravance file for Japanese approval of COPD therapy Anoro Ellipta

GlaxoSmithKline and Theravance announced Monday the submission of a regulatory filing to the Japanese Ministry of Health, Labour and Welfare seeking approval of Anoro Ellipta as a maintenance bronchodilator treatment to relieve symptoms of obstructive airway disorder due to chronic obstructive pulmonary disease (COPD).

The once-daily therapy combines the long-acting muscarinic antagonist umeclidinium bromide and the long-acting beta agonist vilanterol delivered via the Ellipta inhaler. The companies made similar regulatory filings for the once-daily combination therapy in the US in December last year and in Europe in January.

GlaxoSmithKline's respiratory programmes also include the combination therapy Breo Ellipta (fluticasone/vilanterol), which recently received a positive recommendation for approval from an FDA panel (for related analysis, read ViewPoints: FDA approval now more likely for GlaxoSmithKline’s Breo Ellipta but commercial challenges await). The companies have also submitted the therapy to regulators in Europe, where if approved it will be sold as Relvar Ellipta. GlaxoSmithKline noted that it also intends to begin global regulatory submissions for umeclidinium bromide monotherapy later this year.

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