Novartis Reveals Two COPD Drugs’ Positive Phase III Results and NDA Submission

Novartis Reveals Two COPD Drugs’ Positive Phase III Results and NDA Submission

Novartis recently announced robust findings from a pivotal Phase III clinical study for QVA149 (indacaterol/glycopyrronium bromide) and NVA237 (glycopyrronium bromide), meant to support these pipeline medications’ New Drug Applications with the US Food and Drug Administration as potential maintenance for chronic obstructive pulmonary disease (COPD). The positive results come from clinical trial programs EXPEDITION and GEM; both of which successfully met their primary and secondary objectives.

Chronic obstructive pulmonary disease (COPD) is a serious, progressive disease that can greatly reduce one’s quality of life, as the ability to breathe adequately is compromised. There is still no cure for the chronic condition, and current treatments tend to be a hit-and-miss with COPD patients, as many of them remain symptomatic in spite of therapy.

“These data once again confirm the strong efficacy and favorable 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.”

Clinical trials FLIGHT 1 and 2 were successful in treating COPD patients with a twice-daily formulation of QVA149, which demonstrated significant lung function improvements in patients with moderate to severe COPD, compared to indacaterol and glycopyrronium bromide at Week 12 of the study. The studies were also able to evaluate QVA149’s impact on the patients’ overall health, using the St. George’s Respiratory Questionnaire (SGRQ), with adverse effects noted to be similar to those observed in treatment with the drug’s individual components, and with a placebo during EXPEDITION clinical trials 1 and 2.

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As for the findings from clinical trials GEM 1 and 2 with twice-a-day NVA237, the researchers reported notable and clinically meaningful benefits in lung function, in patients with moderate to severe COPD at Week 12, compared to those receiving a placebo. The GEM studies also noted an improvement in the patients’ overall health status, with adverse effects similar to those receiving a placebo during GEM 4 and 5.

Novartis is planning to include these robust findings as part of upcoming medical conferences and symposiums in 2015.

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