GlaxoSmithKline and Innoviva have claimed US approval for Trelegy, their triple therapy for chronic obstructive pulmonary disease, just days after getting a green light from the CHMP in Europe.
The FDA approved Trelegy (fluticasone furoate/umeclidinium/vilanterol) for the long-term, once-daily maintenance treatment of COPD patients who suffer breakthrough exacerbations despite being treated with two-drug combinations.
The three-drug product delivers a long-acting beta agonist (LABA), a long-acting muscarinic antagonist (LAMA) and an inhaled corticosteroid (ICS) from a single device, and is the first product of its type on the market. GSK said it would launch the product in the US very shortly.
Specifically, Trelegy has been approved as an upgraded treatment for patients on GSK’s Breo (fluticasone furoate/vilanterol) and still need to improve airflow or reduce exacerbations, and as an alternative for those on triple therapy with Breo and Incruse (umeclidinium) using two separate inhalers.
The approval and CHMP recommendation last week are the first regulatory nods for Trelegy, which is a critical part of GSK’s plans for the next few years as it tries to engineer a renaissance for its R&D portfolio. In the US it has come in record time, with GSK pulling out all the stops to submit the product to the FDA last November, despite earlier targeting a filing in the first half of next year.
Carving 18 months off the time to market could reap dividends for GSK as Trelegy is expected to become a blockbuster, albeit not hitting the highs of its predecessor Advair/Seretide (fluticasone propionate/salmeterol) which brought in $7bn a year for GSK at peak but contracted to $2.2bn in the first half of the year thanks to generic competition. Analysts at Jefferies have predicted $1.5bn in sales at peak for the new product.
The decline is expected to accelerate once the first generics are launched in the US market next year, which accounts for more than half its sales. Generic drugmakers Hikma and Mylan have both tried to bring Advair generics to market but have been blocked at the final hurdle, while Novartis’ subsidiary Sandoz filed for its version of the drug in June.
With Trelegy now approved, GSK is hoping for a pull-through effect for its two-drug combinations, which are seeing increasing competition from other duos from the likes of Novartis, AstraZeneca and Boehringer Ingelheim. The idea is that with the triple available, patients and physicians will be more likely to select a GSK double to start treatment with, as this effectively means just adding one additional drug to an established treatment regimen.
Meanwhile, analysts have suggested that the early launch will give GSK a window of opportunity to switch patients to its new product before generics hit the US market, and before triples from AZ and Novartis reach the market. In August, Chiesi won EU approval for its closed triple therapy Trimbow (beclometasone, formoterol and glycopyrronium), but that is administered twice-daily.
GSK has acknowledged it has a weak late-stage pipeline and is implementing a turnaround plan under new CEO Emma Walmsley that is designed to deliver a new wave of products from 2022 onwards.