Second late-stage COPD trial for GSK and Theravance
pharmafile | February 10, 2015 | News story | Sales and Marketing | COPD, FF/UMEC/VI, GSK, Theravance, fluticasone furoate, umeclidinium, vilanterol
GlaxoSmithKline and Theravance have begun a second Phase III trial of their investigational triple combination COPD drug as the former company continues to recover its flagging respiratory business.
The FULFIL study will investigate the once-daily closed triple combination of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) – co-developed with Theravance biopharma – compared to AstraZeneca’s twice-daily Symbicort (budesonide/formoterol).
Dave Allen, head of GSK’s respiratory therapy area unit R&D, explains: “Triple combination therapy is already a reality for one in three patients with chronic obstructive pulmonary disease (COPD) and is often dispensed in different inhalers with differing doses.
“By providing all three medicine components in a single inhaler we hope to offer more convenient dosing to patients, reduce the risk of exacerbation compared to dual therapy and, as a result, contribute to the improved management of their disease.”
The UK firm previously had a blockbuster COPD treatment in Advair (fluticasone/salmeterol), but that drug began losing patency in 2013, leading to a severe fall in overall sales for the firm. Investors had worried that the firm was relying too heavily on the medicine.
GSK has been looking to respiratory drugs Relvar (Fluticasone furoate/vilanterol), known as Breo in the US, and Anoro (umeclidinium/vilanterol) to fill the gap left by the drug, but so far uptake has been slow, so much rests on the potential success of FF/UMEC/VI.
The market for COPD drugs is quite crowded at the moment, though – aside from Symbicort there is also Boehringer Ingelheim and Pfizer’s Spiriva (tiotropium bromide) and Novartis’ Ultibro (indacaterol/glycopyrronium), as well as several medicines in development from other firms.
COPD is a progressive and often fatal disease that makes breathing difficult. The World Health Organization estimates that 220 million people worldwide suffer from it, and it affects over three million people in the UK every year. Chronic bronchitis and emphysema are associated with COPD diagnosis.
This is the second Phase III for the triple combination. The larger IMPACT study, which began in July last year, is assessing whether FF/UMEC/VI can reduce the rate of moderate and severe exacerbations compared with GSK’s own Relvar and Anoro.
George Underwood
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