Novartis announces robust Phase III results for QVA149 and NVA237 and submits regulatory applications to US FDA

Novartis International AG / Novartis announces robust Phase III results for QVA149 and NVA237 and submits regulatory applications to US FDA . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• Pivotal Phase III results for QVA149 and NVA237 met their primary endpoints and significantly improved lung function in COPD patients[1-5]
   

US trials for QVA149 demonstrated significant improvements in overall health status compared to placebo[1,2]
 

Submissions to US FDA complete for QVA149 and NVA237 in Q4 2014

Basel, January 8, 2015 - Novartis announced today positive top-line results from the pivotal Phase III clinical trial programs for QVA149 (indacaterol/glycopyrronium bromide) and NVA237 (glycopyrronium bromide) to support New Drug Applications (NDAs) with the US Food and Drug Administration (FDA) for the long-term maintenance treatment of chronic obstructive pulmonary disease (COPD). The results from the EXPEDITION (including FLIGHT 1, 2 and 3 studies) and GEM clinical trial programs met their primary and secondary endpoints.

COPD symptoms can negatively impact a patient's ability to breathe and perform essential daily activities, thereby reducing their quality of life[6,7]. There is an urgent need for new treatment options in COPD because many patients remain symptomatic despite medical therapy[8].

"These data once again confirm the strong efficacy and favourable safety profiles of both QVA149 and NVA237," said Vasant Narasimhan, Global Head of Development, Novartis Pharmaceuticals. "With submissions to the US FDA now complete for both treatments, we are closer to offering US patients with COPD a broader range of treatment options to help improve the significant burden of reduced lung function, and to help improve their lives."

The FLIGHT 1 and 2 studies met their primary objectives with twice-daily QVA149 demonstrating statistically significant and clinically meaningful improvements in lung function (FEV₁ AUC_0-12) at Week 12, compared to indacaterol and glycopyrronium bromide in moderate-to-severe COPD patients[1,2,9]. Improvements in overall health status, a secondary endpoint based on the St George's Respiratory Questionnaire (SGRQ) total score, and rescue medication usage were also seen with QVA149 compared to placebo at Week 12[1,2]. The common adverse events reported for QVA149 were comparable to the individual components and placebo across the EXPEDITION studies[1,2].