Trial could unlock asthma use for GSK’s Trelegy

GlaxoSmithKline CEO Emma Walmsley has been predicting big things for respiratory triple therapy Trelegy in the next couple of years and has new data that could open up a new market.

Top-line results from the CAPTAIN study have shown that Trelegy (fluticasone furoate/umeclidinium/vilanterol) works better than GSK’s two-drug combo Relvar/Breo (fluticasone furoate/vilanterol) at improving lung function in patients living with uncontrolled asthma who struggle to breathe.

The results aren’t all positive – Trelegy wasn’t able to improve on Relvar/Breo when it came to reducing asthma exacerbations and two other doses of Trelegy didn’t perform better than the two-drug regimen on lung function scores.

Nevertheless, GSK R&D chief Hal Barron thinks the triple therapy is still on track for a regulatory filing in uncontrolled asthma once the full dataset is available, and that could extend Trelegy’s indications beyond its current use in chronic obstructive pulmonary disease (COPD).

“We believe a once-daily single inhaler triple therapy that improves lung function is an advance for patients with uncontrolled asthma since this option is not currently available,” he said.

Trelegy is one of the drugs GSK is hoping will help replace its COPD blockbuster Seretide/Advair (salmeterol/fluticasone propionate), which has lost patent protection and seen revenues slide with another 15% decline in the first quarter of this year to £486 million.

The triple therapy was first approved for COPD in late 2017, and while it has struggled to make quick headway in the market there are signs of acceleration after approval last year in an expanded COPD population. First-quarter sales reached £87 million ($113 million), more than half the £156 million tally for 2018 as a whole.

So far Trelegy has been launched in 30 countries and continues to roll out, with recent approvals in Japan and China setting up launches in those big markets later this year.

Uncontrolled asthma is a smaller market than COPD, but isn’t insignificant as it affects around a third of all asthma patients.  Analysts at Jefferies have previously predicted $1.5bn in sales at peak for Trelegy, mostly from COPD but with asthma contributing a portion of that total.