GlaxoSmithKline ($GSK) and Theravance ($THRX) have rolled out a battery of data from a slate of late-stage studies of their LAMA/LABA combo for COPD. And the partners say the numbers will back up their regulatory filings for the treatment beginning at the end of this year as they race promising rivals for an approval.
The headline news here: Their 125/25mcg combination of GSK573719 or meclidinium bromide (UMEC), a long-acting muscarinic antagonist (LAMA) and vilanterol (VI), a long-acting beta2 agonist (LABA) bested Spiriva in a head-to-head study, with a statistically significant improvement for patients on the combo approach. And the dual drug outperformed the individual ingredients as well. In one potential hitch, "UMEC/VI 125/25mcg showed a numerical but not statistically significant improvement (37mL) compared with UMEC 125mcg."
GSK and Theravance are working hip-to-hip on a pair of COPD programs, which are slated to play a key role in replacing Advair. The two companies are also partnered on Relovair, a combo of a LABA and an inhaled corticosteroid which produced some mixed results earlier this year.
"These studies, together with our earlier dose-ranging work, give us confidence that this is a once-daily medicine with the potential to benefit many patients with COPD," says Darrell Baker, GSK's SVP respiratory portfolio optimization leader. "Subject to successful completion of the ongoing studies, we plan to commence global regulatory filings from the end of this year."
GSK and Theravance are by no means alone in the race to get an approval for a LAMA/LABA combo. Novartis ($NVS) has rested its hopes on the late-stage QVA149 – though it has run into dosage issues at the FDA - while Pearl Therapeutics PT003 has already posted positive results compared to Spiriva. Earlier this year PhRMA found a total of 54 COPD studies in the works.
- get the press release
- here's the story from Reuters