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GEN News Highlights : Jun 30, 2011

Novartis Anticipates COPD Drug Filing This Year Following Positive Pivotal Study Data

Second Phase III Glow trial showed long-acting once-daily LAMA drug NVA237 was as effective as tiotropium.

Novartis reported plans to file its COPD candidate NVA237 (glycopyrronium bromide) for approval by year end, on the back of positive data from a second pivotal Phase III study. The Glow2 results demonstrated that the long-acting muscarinic antagonist (LAMA) NVA237 was as effective as tiotropium in terms of 24-hour bronchodilation at 12 weeks.

The 1,066-patient trial also met its key secondary endpoints, including improvement in breathlessness at 26 weeks, quality of life at 52 weeks, time to first COPD exacerbation, and use of rescue medication at 52 weeks. Participants were randomized to receive once-daily NVA237 or placebo on a double-blind basis, or once-daily tiotriopum (open-label), and were permitted to use COPD background therapy and rescue medication. Positive data from the pivotal 26-week Glow1 study was reported back in April.

NVA237 is being developed by Novartis under license from partners Vectura and Sosei. Novartis is separately developing QVA149, a combination of NVA237 with Novartis’ own once-daily long-acting beta2-agonist indacaterol, for the treatment of COPD. The firm says it plans to file for approval of QVA149 in 2012. Indacaterol itself is approved in over 50 countries. An FDA decision on Indacaterol approval is expected in July.