Novartis’ new COPD drug shows efficacy in clinical trial

Novartis has reported positive clinical trial data that supports the safety and efficacy of its new chronic obstructive pulmonary disease (COPD) drug NVA237.

Data from the phase III study Glow2 has shown that a once-daily regimen of the investigational treatment can offer improvements in lung function among patients with moderate-to-severe COPD.

The compound was able to meet its primary efficacy endpoint in the study by delivering a superior performance to placebo, while an exploratory arm of the study showed that it also offers comparable efficacy to open-label tiotropium.

Results from the Glow2 trial will now be utilised to support an application for regulatory approval of NVA237, which will be submitted before the end of the year.

Dr Trevor Mundel, global head of development at Novartis, said: "This new study adds to the growing evidence that NVA237 could be an important treatment option for COPD and supports our plans to develop a fixed-dose combination with our long-acting beta2-agonist Onbrez Breezhaler."

Last month, the company received a recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use for approval of Votubia, its new tuberous sclerosis complex treatment.