Tokyo, Japan – 23 June 2012: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) confirms the information released today by Novartis that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Seebri® Breezhaler® (glycopyrronium/NVA237) 44 mcg delivered dose (50 mcg glycopyrronium per capsule), as a once-daily inhaled maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Seebri Breezhaler is a long-acting muscarinic antagonist (LAMA), a type of bronchodilator that is recommended in COPD global treatment strategies as maintenance therapy administered either alone or in combination with other treatments5.
Data from three of the Novartis Phase III GLOW trials informed the CHMP’s positive opinion for Seebri Breezhaler and included 1,996 COPD patients from around the world with many in EU countries1,2,3,4,6.
GLOW1 demonstrated the clinically significant superiority of Seebri versus placebo for lung function improvements at 12 weeks measured by trough FEV1 (p<0.01)1. GLOW2 demonstrated a similar magnitude of effect and also showed that Seebri was similar to open-label (OL) tiotropium over 52 weeks measured by improvements in trough FEV1 compared to placebo2. In addition to demonstrating benefits in terms of lung function, Seebri Breezhaler exhibited a rapid onset of action within five minutes at first dose2 and reduced exacerbations4. Significant benefits in both breathlessness and health-related quality of life, as measured by the Transition Dyspnea Index (TDI) and St. George’s Respiratory Questionnaire (SGRQ) compared to placebo, were also demonstrated3.
The GLOW3 study showed that after Seebri Breezhaler was administered in the morning, patients experienced improved exercise tolerance from the first dose onward6. Overall, patients treated with Seebri Breezhaler 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)6.
In all studies, Seebri Breezhaler was well tolerated with an incidence of adverse events similar to placebo1,2,3,4,6.
The European Commission generally follows the recommendations of the CHMP and usually delivers its final decision within three months of the CHMP recommendation.
Worldwide submissions and reviews of Seebri® Breezhaler® (glycopyrronium bromide/NVA237) are ongoing. The US filing for Seebri Breezhaler is expected in 2014.
CEO of Sosei, Shinichi Tamura commented:
“This positive opinion for Seebri Breezhaler is a value enhancing milestone for both Sosei and its co-development partner Vectura. The drug was developed to Phase II proof-of-principle by the two companies before being licensed to Novartis and, when approved, will be the second once-daily inhaled treatment in the LAMA class for COPD patients. This innovative therapy has the potential to reduce breathlessness, increase the capacity to exercise and help improve quality of life. We look forward also to key Phase III QVA149 data with filing in Europe expected in 2012”.
1 D'Urzo A, et al. Efficacy and safety of once-daily NVA237 in patients with moderate-to-severe COPD: the GLOW1 trial. Respiratory Research 2011, 12:156 (7 December 2011).
2 Kerwin E, et al. NVA237 once daily provides rapid and sustained bronchodilation in COPD patients, with efficacy similar to tiotropium: The GLOW2 trial. [Abstract A2920: Thematic poster session B41: Monday, 21 May, 2012; 08:15–16:30].
3 Korenblat P, et al. NVA237 once daily improves dyspnea and health-related quality of life in patients with COPD: The GLOW2 trial. [Abstract A2254: Poster discussion session A101: Sunday, 20 May, 2012; 14:00– 16:30].
4 Kerwin E, et al. NVA237 once daily reduces COPD exacerbations with similar rates to tiotropium: The GLOW2 trial. [Abstract A2255: Poster discussion session A101: Sunday, 20 May, 2012; 14:00–16:30].
5 Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. Updated 2011.
6 Beeh K, Drollmann A, Di Scala L, Smith R. Once-daily NVA237 improves exercise endurance from first dose in patients with COPD: the GLOW3 trial. Eur Respir J 2011;38(Suppl. 55):P4497
7 QVA149 A2303 (SHINE). Data on file, Novartis Pharma AG. ClinicalTrials.gov identifier: NCT01202188.
8 QVA149 A2307 (ENLIGHTEN). Data on file, Novartis Pharma AG. ClinicalTrials.gov identifier: NCT01120717.
9 QVA149 2305 (BRIGHT). Data on file, Novartis Pharma AG. ClinicalTrials.gov identifier: NCT01294787.
10 QVA149 2313 (ILLUMINATE). Data on file, Novartis Pharma AG. ClinicalTrials.gov identifier: NCT01315249.
11 Global Alliance Against Chronic Respiratory Diseases (GARD). Global surveillance, prevention and control of chronic respiratory diseases: a comprehensive approach. Available at: http://www.who.int/gard/publications/GARD%20Book%202007.pdf Last accessed 22 May 2012.
12 Fletcher MJ et al., COPD Uncovered: An International survey on the impact of chronic obstructive pulmonary disease (COPD) on a working age population. BMC Public Health 2011;11:612.