According to GlaxoSmithKline and Innoviva, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding wider use of the Trelegy Ellipta fluticasone furoate/umeclidinium/ vilanterol DPI in moderate-to-severe COPD. Trelegy Ellipta was approved in Europe in November 2017 for patients not adequately treated by an ICS and a LABA.
GSK and Innoviva announced submission of a Type II variation application for the expanded indication in February 2018. Approval would make Trelegy Ellipta available to patients who are unable to adequately control their COPD symptoms with a LAMA and a LABA.
In the US, Trelegy Ellipta was initially approved for limited use in the treatment of COPD in September 2017, and the FDA approved an sNDA for use in a wider range of COPD patients in April 2018.
GSK Chief Scientific Officer and President, R&D, Hal Barron commented, “Many patients with COPD continue to experience exacerbations despite taking dual bronchodilator therapies. The landmark IMPACT study provided compelling evidence on the role Trelegy Ellipta can play in reducing these debilitating events. If approved, the indication will recognize this and be expanded to enable more appropriate patients to access the first once-daily single inhaler triple therapy.”
Innoviva Senior VP and Chief Scientific Officer Ted Witek said, “We welcome the CHMP’s recognition of the evidence supporting use of once-daily single inhaler triple therapy in a broader group of appropriate patients with COPD and look forward to a decision from the European Commission in due course.”
Read the GSK and Innoviva press release.
