GlaxoSmithKline, Theravance pull COPD filing for Relvar Ellipta in Japan

GlaxoSmithKline and Theravance announced Friday the withdrawal of a regulatory filing in Japan for Relvar Ellipta (fluticasone/vilanterol) as a treatment for chronic obstructive pulmonary disease (COPD). The companies noted that a marketing application for the once-daily therapy in patients with asthma continues to be reviewed in the country.

According to GlaxoSmithKline and Theravance, the filing for Relvar Ellipta contained data from six studies, including Japanese patient specific efficacy data from two 6-month trials. The drugmakers noted that as no Japanese patients were enrolled in either of the 52-week exacerbation studies of Relvar Ellipta, the results from the 6-month studies alone "may be insufficient to support the efficacy of the combination and its components in this specific patient group."

GlaxoSmithKline and Theravance indicated that they are "determining next steps and possible clinical studies" of Relvar Ellipta for the treatment of Japanese patients with COPD to support a resubmission.

In May, the FDA approved the combination therapy under the name Breo Ellipta for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with COPD. An application is also under review in Europe.

For related results from a recent Physician Views Poll see, US Pulmonologists keen for Breo Ellipta – can payers be convinced?

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