An experimental three-in-one inhaled drug from GlaxoSmithKline significantly cut flare-ups in patients with chronic lung disease in a clinical trial, researchers said.
GSK is ahead of rivals AstraZeneca and Novartis in developing a “closed triple” inhaler and plans to file the new treatment for chronic obstructive pulmonary disease (COPD) for regulatory approval this year.
The study found patients taking the new triple therapy for 24 weeks had 35 percent fewer moderate or severe exacerbations compared to those on AstraZeneca’s two-in-one Symbicort. The reduction was 44 percent in a subset treated for up to 52 weeks.
Such flare-ups are a major concern in COPD since they cause breathing problems that can be life-threatening.
GSK, the global leader in respiratory medicine, is facing competition from cheap generics to its older Advair inhaler, prompting the company to invest in novel therapies.
Although there is some debate as to how doctors would decide when to move patients onto triple therapy, GSK views the new inhaler as a big opportunity and CEO Andrew Witty has said it could be an “absolute clincher” for its respiratory strategy.
Britain’s biggest drugmaker and its partner Innoviva had reported in June that the clinical trial met its main goals of improving lung function and quality of life, but the secondary exacerbation data was only revealed at the European Respiratory Society congress in London this week.
GSK’s once-daily triple inhaler combines the drugs fluticasone, umeclidinium and vilanterol. The idea is to use three different mechanisms to help open the airways of patients with more severe disease.
Another large clinical trial looking at this combination’s ability to reduce COPD exacerbations is expected to complete in 2017.
GSK’s former blockbuster Advair already faces generic competition in Europe and could see the arrival of cheap copycats in the United States next year. But the group still believes it can grow respiratory medicine sales, driven by the forthcoming launch of the triple product and other new drugs.