GSK and Theravance Submit Supplemental Japanese New Drug Application for Relvar Ellipta for COPD Management

Patrícia Silva, PhD avatar

by Patrícia Silva, PhD |

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GlaxoSmithKline (GSK) and Theravance, Inc. recently announced in a press release their plans to file for a joint-supplemental Japanese New Drug Application (sJNDA) for their collaboratively developed chronic obstructive pulmonary disease (COPD) treatment, Relvar® Ellipta® (fluticasone furoate “FF”/vilanterol “VI” or “FF/VI” or Breo Ellipta). The partners aim to submit the application within the first quarter of 2016 – a move that is soon to be backed by findings from an additional international Phase III study on the drug’s efficacy and safety profile.

This Phase III study, dubbed “Study 200820”, sought to address the research gap on the efficacy data of FF/VI, compared with its component, VI, in patients with moderate to severe COPD. The study enrolled 1,620 COPD patients, out of which 370 were Japanese. Findings showed that patients who were treated with FF/VI 100/25mcg exhibited a significantly greater improvement in lung function, compared to those who only received VI 25mcg at 12 weeks.

As for any untoward side effects of the treatment, a minority of patients reported temporary and resolvable instances of nasopharyngitis (6% VI, 6% FF/VI), COPD exacerbation (4% VI, 2% FF/VI) and headache (2% VI, 4% FF/VI), with 7 patients developing pneumonia as an adverse effect.


BREO® ELLIPTA® 100/25 is a combination inhaled corticosteroid/long-acting beta2-adrenergic agonist (ICS/LABA) indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. BREO ELLIPTA 100/25 is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. BREO ELLIPTA 100/25 once daily is the only strength indicated for the treatment of COPD.

Prescribing bronchodilators for patients with chronic obstructive pulmonary disease (COPD) with varying levels of disease severity can be a difficult task for clinicians and healthcare professionals. Of late, several combinations of bronchodilators were approved for patient use in COPD and other respiratory diseases. In a recent article entitled “Comparative efficacy of combination bronchodilator therapies in COPD: a network meta-analysis” and published in the International Journal of Chronic Obstructive Pulmonary Disease,  researchers assessed the comparative efficacy of new bronchodilator combinations over other bronchodilator options in a network meta-analysis (NMA) that tested umeclidinium and vilanterol (UMEC/VI) against other dual bronchodilators available as inhalable formulations.