GSK's new once-daily inhaled fluticasone product worked in Phase 2 trial (RCT, Thorax)
GlaxoSmithKline has a new once-daily inhaled corticosteroid called fluticasone furoate; it has enhanced affinity for glucocorticoid receptors and a longer duration of action compared to the commonly-used fluticasone propionate, which must be taken twice daily to achieve a steady bioavailable concentration.
In the January Thorax, William Busse et al report the findings of a Phase 2 clinical trial testing the new fluticasone furoate against fluticasone propionate or placebo. GlaxoSmithKline funded the study, and through their ghostwriters, Gardiner-Caldwell Communications, wrote this manuscript, according to the disclosures.
GSK and the investigators randomized 627 patients with moderate to severe asthma uncontrolled on medium-dose inhaled corticosteroid to receive fluticasone furoate in one of four doses (200-800 mcg once daily), fluticasone propionate 500 mcg twice daily, or placebo, for 8 weeks.
The new once-daily inhaled fluticasone furoate was at least similar in efficacy to fluticasone propionate at all doses for achieving improvement in pre-dose FEV1 from pre-treatment baseline (the primary endpoint). The 200 mcg dose was as efficacious as 800 mcg.
The larger story here is the race by GSK to develop and gain regulatory approval for a once-daily inhaled combination product for asthma and chronic obstructive pulmonary disease (COPD), to retain market share and revenue as its $8 billion blockbuster Advair's patents expire, beginning in Europe in 2013. GSK's new combination product is called RelovairTM, and contains fluticasone furoate and the once-daily long-acting beta agonist vilanterol. Glaxo has multiple studies going on testing RelovairTM in COPD and asthma.
GSK's Advair is the third-leading drug in the world in revenues today, and the global market for asthma/COPD drugs is expected to rise to $44 billion yearly in 2015, up 36% from today's $32 billion. As trial data for Relovair emerges, it's showing itself to be roughly equally efficacious to Advair, but not better. Investors haven't liked that, knocking down GSK's stock price by 4% on the announcement of results from a recent trial.
Glaxo should submit Relovair for FDA approval in mid-2012. Multiple Pharmas including Novartis, GSK and Forest Labs are testing non-steroid once-daily products, combining long-acting antimuscarinic with long-acting beta agonist, as well.
Busse WW et al. Fluticasone furoate demonstrates efficacy in patients with asthma symptomatic on medium doses of inhaled corticosteroid therapy: an 8-week, randomised, placebo-controlled trial. Thorax 2012;67:35-41.