Swiss pharmaceutical giant Novartis AG (NVS: Quote) on Monday said its first three QVA149 Phase III studies in the treatment of chronic obstructive pulmonary disease or COPD all met their primary endpoints.
QVA149, a bronchodilator with dual mode of action, is Novartis' third innovation in its Breezhaler single dose dry powder inhaler.
According to the company, the SHINE, BRIGHT and ENLIGHTEN studies demonstrate the potential of QVA149 in the treatment of COPD. The studies are components of the IGNITE Phase III clinical trial program intended to form the basis for an NDA filing in COPD.
The results of SHINE met the primary endpoint by demonstrating the superiority in trough FEV of once-daily QVA149 compared to once-daily indacaterol or once-daily NVA237 in patients with moderate to severe COPD.
The results of BRIGHT demonstrated that patients experienced significantly better exercise endurance versus placebo and ENLIGHTEN showed that QVA149 was well tolerated with a safety and tolerability profile similar to placebo.
Tim Wright, Head of Development, Novartis Pharmaceuticals, said, "Meeting the primary endpoints in the IGNITE Phase III clinical trial program signals significant progress in establishing the potential of QVA149, which is expected to be the third innovative medicine in our strong COPD portfolio."
The company noted that the data from the IGNITE clinical trial program examining QVA149 in a number of settings will be submitted for presentation to a major medical congress later this year.
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by RTT Staff Writer
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