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Novartis files Vectura NVA237 with EMA for marketing authorization

Vectura Group, which develops inhaled therapies for respiratory diseases, has announced that Novartis has filed NVA237 (glycopyrronium bromide) for marketing authorisation with the European Medicines Agency (EMA) under the brand-name Seebri Breezhaler.

Following the move, Vectura will receive a payment of $5m.

Novartis has presented new NVA237 Phase III data at the European Respiratory Society (ERS) congress.

The Glow1 and Glow3 studies in chronic obstructive pulmonary disease (COPD) patients show that NVA237 (glycopyrronium bromide) increased patients’ lung function compared to placebo.

The findings of Glow1 study revealed that NVA237 50 mcg once-daily produced a significant improvement in lung function of 108 mL in trough FEV1 (forced expiratory volume of breath in one second) after 12 weeks in patients with moderate-to-severe COPD compared to placebo.

The Glow3 study evaluated the effects of NVA237 50 mcg once-daily on exercise endurance in moderate-to-severe COPD patientsand showed 21% improvement in exercise endurance versus placebo at the end of the study.