GlaxoSmithKline, Theravance report positive Phase III results for COPD regimen

GlaxoSmithKline and Theravance on Wednesday said data from two Phase III studies demonstrated that adding the anticholinergic Incruse Ellipta (umeclidinium) to Breo Ellipta (fluticasone furoate/vilanterol) significantly improved lung function in patients with chronic obstructive pulmonary disease (COPD), compared with Breo Ellipta plus placebo. Darrell Baker, head of GlaxoSmithKline's global respiratory franchise, said the results "are an important addition to the evidence base supporting the efficacy and safety of Incruse," adding that "these studies are also the first to investigate the combined effect of two of the newest medicines from our respiratory portfolio."

The trials involved 1238 patients with an established clinical history of COPD and a forced expiratory volume in one second (FEV1) of 70 percent or less. Patients were randomised to once-daily treatments with either one of two doses of Incruse Ellipta plus Breo Ellipta, or Breo Ellipta plus placebo. In both 12-week studies, the combination treatments were associated with significant improvements in the primary endpoint of trough FEV1 at day 85, versus Breo Ellipta alone. The drugmaker indicated that full study results would be presented at a future scientific meeting.

Incruse Ellipta was recently cleared by regulatory authorities in the US, Canada and Europe for the treatment of COPD. The FDA approved Breo Ellipta for COPD in May 2013, while the therapy was later granted approval by European regulators for the same indication under the name Relvar Ellipta. The product is also marketed in Japan under the Relvar Ellipta brand as a treatment for bronchial asthma, while GlaxoSmithKline and Theravance withdrew their Japanese application for the medicine in the COPD indication last July.

For related analysis, read ViewPoints: Streamlined and refocused, but GlaxoSmithKline needs respiratory portfolio to deliver and Physician Views Poll Results: Stuttering start for GlaxoSmithKline's Breo extends beyond reimbursement issues...but sentiment remains high for Anoro.

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