GlaxoSmithKline (GSK) and Theravance have started a major new study of a three-drug combination for chronic obstructive pulmonary disease (COPD) delivered via a single inhaler once a day.
Around a third of COPD patients are already receiving triple therapy to help manage the disease, but have to rely on “different inhalers with differing doses”, according to Dave Allen, head of respiratory R&D at GSK.
The company wants to put a corticosteroid, long-acting beta agonist (LABA) and long-acting muscarinic antagonist (LAMA) in a single device as this will not only improve convenience for patients but may reduce the risk of COPD exacerbations compared to dual therapies.
The latest phase III trial – called FULFIL – will compare the trio of fluticasone, umeclidinium and vilanterol to AstraZeneca’s twice-daily therapy Symbicort (budesonide and formoterol) on lung function, exacerbation rates and safety in 1,800 COPD patients.
A larger 10,000-patient trial of the combination got underway last year and is due to complete in 2017.
GSK has been a dominant force in the COPD sector for years with its blockbuster steroid/beta agonist dual therapy Advair (salmeterol and fluticasone), although the latter faced increasing competition and pricing pressure – particularly in the US – over the course of 2014.
The performance of GSK’s respiratory portfolio dragged down group revenues as a whole last year, and GSK is now banking on a series of new products launches – including LAMA/LABA combination Anoro (umeclidinium and vilanterol) and Advair follow-up Relvar/Breo (fluticasone furoate and vilanterol) – to get the division back on track.
That could be a tough call, however, as the COPD sector is becoming increasingly crowded with new LAMA/LABA combinations such as Novartis‘ Ultibro (indacaterol and glycopyrronium bromide) and AZ‘s Duaklir (formoterol fumarate and aclidinium bromide) jostling for market share.
Analysts have predicted that the new dual therapy entrants are unlikely to reach the $7bn-a-year in sales enjoyed by Advair and are much more likely to be in the $1bn-$2bn range, but GSK will be hoping its triple therapy will do somewhat better given generic versions of Advair are due in Europe this year and potentially in the US in 2016.
One set back for the triple therapies came last year, however, when a study reported at the European Respiratory Society ERS) meeting found that removing the steroid component from a triple therapy had no impact on the frequency of exacerbations among moderate-to-severe COPD patients.
Analysts at Deutsche Bank have suggested this could limit interest in triple therapies, although a poll of respiratory specialists carried out last year by First Word suggested that almost two thirds felt these combinations could be a ‘paradigm shift’ in COPD comparable to the launch of Advair in the category.