GlaxoSmithKline and Innoviva have presented data from the FULFIL study of its fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) DPI versus Symbicort for COPD, reiterating that the data support the company’s plans to file an NDA for the product by the end of the year as recently announced as well as filing for approval in the EU by the end of 2016. The study met both of its primary endpoints, showing statistically significant improvement in lung function and in quality of life compared to Symbicort Turbuhaler.
The FULFIL (Lung FUnction and quality of LiFe assessment in COPD with closed trIpLe therapy) Phase 3 study, which enrolled over 1,800 COPD patients, began in early 2015. Another study, called IMPACT (InforMing the PAthway of COPD Treatment), began in 2014 and is expected to be completed in 2017, expected to enroll approximately 10,000 patients in 38 countries to evaluate the triple therapy’s reduction of exacerbations versus Relvar/Breo Ellipta and Anoro Ellipta.
GSK Head of Respiratory R&D Dave Allen said, “We are delighted with the outcome of the FULFIL study, which marks a further step towards making this closed triple combination therapy available to appropriate patients with COPD. Triple combination therapy is already a reality for many patients with COPD and is dispensed in multiple inhalers. By combining three medicines in a single inhaler we can offer a convenient, once-daily dosing option to patients while improving their symptoms.”
Innoviva CEO Mike Aguiar, added, “With the FULFIL study, we have shown meaningful improvements in lung function and health-related quality of life when combining three COPD medicines in a single inhaler, compared to the dual therapy of budesonide/formoterol. If approved, a once-daily triple combination would be an important addition to our portfolio of combination respiratory products partnered with GSK including Relvar/Breo Ellipta and Anoro Ellipta.”
Read the GSK and Innoviva press release.
