SoseiGroup Corporation confirmed the information released today by Novartis thatresults from the pivotal Phase 3 GLOW2 study demonstrated that once-daily 50mcgNVA237 (glycopyrronium bromide) was superior to placebo in improving lungfunction, symptom relief and quality of life, and reducing exacerbations over aone-year period in patients with chronic obstructive pulmonary disease (COPD).
GLOW2 wasa 52-week double-blind, placebo-controlled, parallel-group study involving1,066 patients to assess the efficacy, safety and tolerability of NVA237 inpatients with COPD. Patients were randomized into three treatment armsreceiving either once-daily NVA237 50mcg or placebo (double-blind), oronce-daily OL tiotropium (Spiriva HandiHaler; Boehringer Ingelheim) 18mcg. Theywere also permitted to use COPD background therapy and rescue medication.
GLOW2 metits primary endpoint by demonstrating NVA237 provided superior 24-hourbronchodilation 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 withmoderate-to-severe chronic obstructive pulmonary disease (COPD). NVA237 alsodemonstrated rapid onset of action (within five minutes at first dose) andsustained 24-hour bronchodilation over 52 weeks.
NVA237 is a once-daily, long-actingmuscarinic antagonist (LAMA).
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