AstraZeneca has said it is ready to file for approval of its chronic obstructive pulmonary disease (COPD) triple therapy before the end of the year, after publishing phase 3 data for the new drug.
The KRONOS trial of PT010 – which combines long-acting beta agonist (LABA) formoterol fumarate, long-acting muscarinic antagonist (LAMA) glycopyrronium and inhaled corticosteroid (ICS) budesonide – was presented at a medical congress yesterday and simultaneously published in The Lancet.
The data reveals that the drug was better than two-drug combinations in preventing COPD exacerbations, reducing attacks by 52% compared to AZ’s LAMA/LABA combination Bevespi (glycopyrronium/formoterol fumarate). It was however unable to show a significant improvement over two other drugs, Symbicort Turbuhaler (budesonide/formoterol fumarate) and PT009 (budesonide/formoterol fumarate).
At the moment GSK is the only company with a three-drug combination for COPD approved for marketing on both sides of the Atlantic, getting a green light for its Trelegy triple – based on LABA vilanterol, LAMA umeclidinium and ICS fluticasone furoate – in the US and Europe last year.
First to market in Europe was Chiesi with its Trimbow (formoterol fumarate, glycopyrronium and beclomethasone) product, although this has to be administered twice-daily while Trelegy and PT010 are dosed just once per day.
AZ has previously said it will file for approval in Japan and China before the end of this year, and in the US and Europe in early 2019. It has another phase 3 trial ongoing – called ETHOS – that the company’s head of respiratory medical Colin Reisner says will “further characterise PT010” as it sets off in pursuit of Trelegy.
AZ’s competitive position in COPD is still hard to gauge, given Trelegy’s long-lead in the market and a disappointment for Bevespi in a recent clinical trial which pitted it against GSK’s two-drug LAMA/LABA Anoro (umeclidinium/vilanterol). As the two drug combinations are at the heart of both companies’ triple therapies, that could undermine PT010 in the eyes of clinicians – although AZ has insisted the read-out doesn’t tally with previous data on Bevespi.
There’s still all to play for, and it’s important for both companies that KRONOS adds to the body of data showing that adding an ICS to LAMA/LABA combinations improves efficacy in COPD. Trelegy hasn’t been growing particularly quickly since its approval a year ago in the US, with £37m ($48m) in revenues in the first six months of the year, while Anoro contributed £217m. Bevespi made $13m in the same period.