Phase 3 Trial Update of NVA237 for COPD

Sosei Group Corporation confirmed the information released today by Novartis that results from the pivotal Phase 3 GLOW2 study demonstrated that once-daily 50mcg NVA237 (glycopyrronium bromide) was superior to placebo in improving lung function, symptom relief and quality of life, and reducing exacerbations over a one-year period in patients with chronic obstructive pulmonary disease (COPD).

GLOW2 was a 52-week double-blind, placebo-controlled, parallel-group study involving 1,066 patients to assess the efficacy, safety and tolerability of NVA237 in patients with COPD. Patients were randomized into three treatment arms receiving either once-daily NVA237 50mcg or placebo (double-blind), or once-daily OL tiotropium (Spiriva HandiHaler; Boehringer Ingelheim) 18mcg. They were also permitted to use COPD background therapy and rescue medication.

GLOW2 met its primary endpoint by demonstrating NVA237 provided superior 24-hour bronchodilation compared to placebo at 12 weeks measured by mean trough FEV1 (97mL; P<0.001). At this same time point, trough FEV1 for open-label (OL) tiotropium 18mcg was 83mL versus placebo (P<0.001). In addition, NVA237 showed similar efficacy to OL tiotropium in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). NVA237 also demonstrated rapid onset of action (within five minutes at first dose) and sustained 24-hour bronchodilation over 52 weeks.

NVA237 is a once-daily, long-acting muscarinic antagonist (LAMA).

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