Sosei Group Corporation ("Sosei"; TSE Mothers Index: 4565) confirms the information released today by Novartis that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Seebri® (glycopyrronium bromide) Inhalation Capsules 50 mcg administered through the Breezhaler® device, as a once-daily, long-term, inhaled maintenance bronchodilator treatment for the relief of various symptoms due to airway obstructive disease in chronic obstructive pulmonary disease (chronic bronchitis and emphysema). This marks the first approval for glycopyrronium, with approval also expected in the EU in 2012, and triggers a $2.5m milestone payment to Sosei.
The MHLW approved Seebri® Inhalation Capsules based on data from the Novartis Phase III GLOW trials which demonstrated the safety and efficacy of glycopyrronium 50 mcg and involved 2,159 COPD patients from Japan and around the world who required maintenance treatment.
The GLOW trials showed that glycopyrronium, when compared to placebo, significantly improved lung function over the first four hours after morning dosing and that this benefit was sustained for 24 hours over a 52-week period. Patients on glycopyrronium demonstrated improved lung function, reduced shortness of breath, reduced exacerbations, reduced use of rescue medication, and improved quality of life compared to placebo.
GLOW1 was a 26-week, randomized, double-blind, placebo-controlled study. The study demonstrated the clinically significant superiority of glycopyrronium versus placebo for lung function improvements at 12 weeks (primary endpoint) measured by trough FEV1 (p<0.01).
GLOW2 demonstrated a similar magnitude of effect and also showed that glycopyrronium was similar to open-label (OL) tiotropium over 52 weeks measured by improvements in trough FEV1 compared to placebo. In addition to demonstrating benefits in terms of lung function, glycopyrronium exhibited a rapid onset of action within five minutes at first dose and reduced exacerbations. Significant benefits in both breathlessness and health-related quality of life (HRQL), as measured by the Transition Dyspnea Index (TDI) and St. George's Respiratory Questionnaire (SGRQ) compared to placebo, were also demonstrated. GLOW2 was a 52-week, randomized, double-blind, placebo-controlled study with OL tiotropium 18 mcg as an active exploratory arm.
The GLOW3 study showed that after glycopyrronium was administered in the morning, patients experienced improved exercise tolerance from the first dose onward. Overall, patients treated with glycopyrronium experienced a significant 21% improvement in exercise endurance versus placebo at the end of the study (day 21), with a significant 10% increase from day one (both p<0.001).
GLOW4 was a 52-week study in a Japanese population that examined the safety profile of glycopyrronium using OL tiotropium 18 mcg administered in the Handihaler® device as an active control. The data from this study showed that glycopyrronium had a similar safety profile to OL tiotropium. In all studies, glycopyrronium was shown to have an overall safety profile similar to placebo.
CEO of Sosei, Shinichi Tamura commented:
"We are delighted with the MHLW approval of Seebri Inhalation Capsules which marks an important milestone in the evolution of the Sosei business.
The latest Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines recommend long-acting muscarinic antagonists as first-line therapy for a broad range of COPD patients with moderate to very severe symptoms. Seebri Inhalation Capsules will provide an important once-daily treatment option for this serious disease."
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