Date: 2012-01-09
Type of information:
phase: 3
Announcement: completion of the phase III registration programme
Company: GSK (UK) Theravance (USA)
Product: Relovair®
Action
mechanism: Relovair® is a once-daily inhaled corticosteroid (ICS)/long-acting beta-agonist (LABA) combination treatment, comprising fluticasone furoate and vilanterol (FF/VI), currently under development for the treatment of COPD and asthma.
Disease: chronic obstructive pulmonary disease (COPD)
asthma
Therapeutic area: Allergic diseases - Inflammatory diseases - Respiratory diseases
Country:
Trial details: The COPD programme included two replicate 52-week exacerbation studies each of which randomised approximately 1,620 patients. The studies were powered to compare each of 3 doses of FF/VI (200/25mcg, 100/25mcg and 50/25mcg) to VI 25mcg alone in a step-wise manner, starting at the highest dose. In both studies, all doses of FF/VI demonstrated reductions in the annual rate of moderate to severe exacerbations compared with VI alone.
Latest
news: GSK and Theravance have announced the completion of the phase III registration programme for the once-daily investigational medicine Relovair™ (fluticasone furoate “FF”/vilanterol “VI”) in patients with chronic obstructive pulmonary disease (COPD) and of all but one of the pivotal studies in patients with asthma.
For COPD, GSK intends to submit regulatory applications in the US and Europe in mid-2012.
For asthma, GSK plans to submit an application in Europe in mid-2012 and will continue discussions with the FDA on the regulatory requirements for a US asthma indication.
The full results of these pivotal studies will be presented at future scientific meetings.
In both studies of the COPD programme, all doses of FF/VI demonstrated reductions in the annual rate of moderate to severe exacerbations compared with VI alone. In the first study, the reductions were statistically significant at all doses (200/25mcg p<0.001, 100/25mcg p=0.024, 50/25mcg p=0.040). In the second study, the reductions were not statistically significant at the highest dose (200/25mcg). The p-values in this study were p=0.109 (200/25mcg), p<0.001 (100/25mcg) and p=0.181 (50/25mcg).
GSK and Theravance believe that it is appropriate to request that regulatory authorities review the totality of the exacerbation data, including the effects seen across both studies for the 100/25mcg dose. In both exacerbation studies, all doses of FF/VI demonstrated numerical increases in lung function compared with VI, but not all increases were significant.
Across these two studies, the most common adverse events in the FF/VI arms included nasopharyngitis, upper respiratory tract infection, oral candidiasis, headache, COPD, back pain, pneumonia, bronchitis and sinusitis. GSK is investigating reports of fatal pneumonia on FF/VI primarily at the 200/25mcg dose. An integrated safety and tolerability analysis is underway.
A 4-week detailed lung function profile study in 54 patients demonstrated that all doses of FF/VI (50/25mcg, 100/25mcg, and 200/25mcg) statistically significantly increased weighted mean FEV1 versus placebo.
In a non-pivotal 12-week superiority study of FF/VI 100/25mcg once daily compared with Seretide® (fluticasone propionate/salmeterol (FP/SAL)) 500/50mcg twice daily, FF/VI did not meet the predefined threshold for superiority on 0-24 hour weighted mean FEV1(p=0.282). There was no statistical difference between FF/VI and FP/SAL.
GSK anticipates filing the FF/VI 100/25mcg dose for COPD on a global basis starting in mid-2012.
