LONDON (dpa-AFX) - GlaxoSmithKline plc (GSK, GSK.L) and Innoviva, Inc. (INVA) announced Thursday that the landmark IMPACT study published in the New England Journal of Medicine or NEJM showed significant benefits of Trelegy Ellipta for patients with chronic obstructive pulmonary disease or COPD.
The once-daily single inhaler triple therapy is superior to Relvar/Breo Ellipta and Anoro Ellipta across multiple endpoints including exacerbations, lung function and quality of life, the company noted.
According to the company, off-treatment data also need to be considered to fully understand the implications of the all-cause mortality observation. Work is ongoing to investigate this further and will be presented at future scientific meetings.
Dave Allen, Head, Respiratory Therapy Area R&D, GSK, said, 'Reducing exacerbations to keep patients out of hospital is a key goal of COPD management alongside improving lung function and quality of life. The IMPACT study shows how Trelegy Ellipta can help patients with a history of exacerbation achieve these goals. We believe its publication in NEJM is an important addition to the evidence base that informs the management of this progressive and debilitating disease.'
Results from IMPACT were submitted to the regulatory authorities in the US and EU in November 2017 and February 2018, respectively. Further regulatory submissions in other countries are expected in 2018.
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