GSK receives positive opinion for triple-therapy inhaler

GSK, alongside its partner Innoviva, has announced that it has received a positive opinion from the EMA’s CHMP for its Trelegy Ellipta treatment for chronic obstructive pulmonary disease (COPD).

The inhaler combines fluticasone furoate, umeclidinium and vilanterol as part of maintenance treatment for the condition in those who do not respond suitably to a combination of an inhaled corticosteroid and a long-acting beta2-agonist.

Should GSK receive approval from the EC, something it noted it expects by the end of 2017, the treatment would become the first triple therapy available for COPD on the market.

The move to bring the product before regulators took the industry by surprise, coming 18 months ahead of the expected filing. The introduction of a triple therapy aims to preserve GSK’s dominance in the respiratory market, after the release of Advair secured a dominant position but will soon face generic competition.

GSK were given breathing room before the inevitable release of generic versions after Mylan had its competitor knocked back by an FDA CRL. It means that Trelegy Ellipta, all being well, could emerge onto the market before any generic competitors to Advair arrive – further allowing GSK to cement its position.

The potential benefit of bringing the new inhaler onto the market is that doctors, if considering the need to prescribe the triple-therapy inhaler are more likely to begin patients first on Advair as part of the same brand.

Patrick Vallance, GSK’s President, R&D, said, "We believe once-daily single inhaler triple therapy, if approved, would provide an important option for appropriate patients with COPD who are receiving ICS/LABA and require additional bronchodilation, avoiding the need for multiple inhalers."

Mike Aguiar, CEO of Innoviva, Inc. said, "This positive opinion will lead to a significant therapeutic convenience for those appropriate patients already on ICS/LABA treatment that require additional bronchodilation. Trelegy is the latest development in our collaboration with GSK and is testament to our ongoing efforts to advance respiratory medicine."

GSK has also applied for marketing approval through the FDA, as well as regulators in Australia and Canada.