GSK, Theravance Studying Combination Drug in Phase III for COPD

A Phase III safety and efficacy study recently kicked off in Japan by UK drugmaker GlaxoSmithKline and San Francisco’s Theravance will evaluate the effect of inhaled corticosteroid fluticasone furoate on chronic obstructive pulmonary disease patients’ lung function, the companies said Tuesday.

The companies intend to enroll 1,580 patients with at least one exacerbation in the last year at 250 centers around the world in the 12-week, multi-center, randomized, double-blind and parallel-group study evaluating a once daily dose of the drugs via the Ellipta inhaler.

Results of the current study should be available sometime next year, said GSK spokeswoman Eleanor Bunch.

Japan’s Ministry of Health, Labour and Welfare already approved the combination under the name Relvar Ellipta for asthma patients in September. The drugmakers are hopeful that positive results from this trial will support a Japanese COPD indication.

GSK previously withdrew its COPD filing in Japan after results from two six-month efficacy studies showed that fluticasone furoate showed numerical, but not statistically significant, effects on lung function.

Since Japanese patients were not enrolled in any 52-week exacerbation studies, GSK felt that a new trial may better support the drug’s benefits on patients’ lung function, Bunch told Drug Daily Bulletin.

Japan’s COPD market is dominated by Novartis’ Seebri (glycopyrronium) and Ultibro’s (indacaterol/glycopyrronium) breezhalers.The FDA approved FF/VI under the name Breo Ellipta for COPD in May of last year. The crowded U.S. COPD market includes drugs from Forest Laboratories, Almirall, Pfizer, AstraZeneca and Boehringer Ingelheim. — Lena Freund

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