Novartis’ investigational combination indacaterol/glycopyrronium bromide therapy for COPD performed better than its constituent components in a Phase III clinical trial, according to the company.
The candidate (QVA149) met its clinical endpoint and demonstrated clinically meaningful improvements in lung function at 12 weeks compared to either ingredient alone or placebo, Novartis said.
QVA149 is marketed as the Ultibro Breezhaler outside the US, including the European Union, Latin America, Japan, Canada, Switzerland and Australia, where it is to be taken once a day, though it is being investigated for twice-a-day use in the US.
The company expects to hear word on FDA approval (or rejection) of the combo drug in the second half of this year.
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