Press release
May 21, 2015

Two positive US phase III programs in COPD for QVA149 and NVA237


  • QVA149 improved lung function, breathlessness and health-related quality of life in moderate-to-severe COPD patients, according to EXPEDITION trial results1-7 
  • GEM 1 & 2 studies showed NVA237 provided significant and clinically meaningful improvements in lung function in moderate-to-severe COPD patients8,9
 
Tokyo, Japan – 21 May 2015: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) confirms the positive results announced today by Novartis from two pivotal Phase III clinical trial programs for QVA149 (indacaterol/glycopyrronium bromide) and NVA237 (glycopyrronium bromide) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). The EXPEDITION (including FLIGHT 1, 2 and 3 studies) and GEM programs met their primary and secondary endpoints, and the results were presented for the first time at the ATS International Conference, 15-20 May 2015, in Denver, US1-9.
 
Data from the EXPEDITION program demonstrated that QVA149, administered twice daily, improved lung function (FEV1 AUC0-12h) compared to placebo and its individual monocomponents, indacaterol and glycopyrronium bromide (p<0.001), after 12 weeks of treatment, meeting its primary objective1-2. Further findings also confirmed that Novartis’ dual bronchodilator improved breathlessness, overall quality of life and COPD rescue medication use1-4. It also showed significant improvements in FEV1 at 5 min and 15 min compared to placebo according to new pooled data from over 2,000 patients5.
 
In the GEM 1 and 2 studies, NVA237, administered twice-daily, demonstrated significant and clinically meaningful improvements in lung function (FEV1 AUC0-12h) at week 12 in moderate-to-severe COPD patients compared to placebo (p<0.001); meeting its primary objective8,9. Improvements in COPD symptoms, quality of life and rescue medication use in patients with moderate-to-severe airflow limitation were also observed8,9.
 
The safety profiles of QVA149, its monotherapy components and placebo were broadly similar across the EXPEDITION studies6,7, as was NVA237 to indacaterol and placebo in the GEM studies8,9.
 
There is an urgent need for new COPD treatments in the US as many people remain symptomatic despite receiving medical care10. Reflecting this, evidence from the EXPEDITION and GEM programs presented today has also been used by Novartis to support current QVA149 and NVA237 US regulatory submissions.
 
References
1. Kerwin EM, Fowler Taylor A, Ayers T et al. QVA149 improves lung function to a greater extent than monocomponents in patients with moderate-to-severe COPD: The FLIGHT 1 Study. [ATS abstract 62856; Session D36; Date: Wednesday, May 20, 2015; 9:30am - 3:30pm].
2. Kerwin EM, Ayers T, Fowler Taylor A et al. QVA149 provides superior improvement in lung function versus its monocomponents in patients with moderate-to-severe COPD: the FLIGHT 2 study [ATS abstract 62690; Session D36; Date: Wednesday, May 20, 2015; 9:30am - 3:30pm].
3. Jones P, Mahler D, Fowler Taylor A, Ayers T et al. QVA149 show superior improvements in quality of life, as measured by SGRQ, compared with placebo in patients with moderate-to-severe COPD: the FLIGHT 2 study. [ATS abstract 62846; Session D36; Date: Wednesday, May 20, 2015; 9:30am - 3:30pm].
4. Mahler D, Fowler Taylor A, Ayers T et al. QVA149 reduces dyspnea in patients with moderate-to-severe COPD as measured by the transition dyspnea index: the FLIGHT 2 study [ATS abstract 61730; Session D36; Date: Wednesday, May 20, 2015; 9:30am - 3:30pm].
5. Banerji D, Fowler Taylor A, Ayers T et al. QVA149 shows rapid onset of bronchodilation versus placebo and its mono-components in patients with moderate-to-severe COPD: pooled data from the FLIGHT studies. [ATS abstract 62677; Session D36; Date: Wednesday, May 20, 2015; 9:30am - 3:30pm].
6. Fowler Taylor A, Ayers T, Thach C et al. Safety of QVA149 versus its monocomponents and placebo: a pooled safety analysis from FLIGHT 1 and FLIGHT 2 studies. [ATS abstract 63617; Session D36; Date: Wednesday, May 20, 2015; 9:30am - 3:30pm].
7. Ferguson G, Fowler Taylor A, Ayers T et al. QVA149 is safe and well tolerated in patients with moderate-to-severe COPD: FLIGHT 3, a 52-week safety study. [ATS abstract 63609; Session D36; Date: Wednesday, May 20, 2015; 9:30am - 3:30pm].
8. LaForce C, Pearle J, Feldman G, et al. efficacy and safety of glycopyrronium in COPD patients with moderate-tosevere airflow limitation: The GEM 1 Study. [ATS abstract 62680; Session D36; Date: Wednesday, May 20, 2015; 9:30am - 3:30pm].
9. Kerwin EM, Siler TM, Korenblat PE et al. Glycopyrronium twice daily improves lung function and quality of life and is well tolerated in COPD patients with moderate-to-severe airflow limitation: The GEM 2 Study. [ATS abstract 63673; Session D36; Date: Wednesday, May 20, 2015; 9:30am - 3:30pm].
10. Price D, West D, Brusselle G, et al. Management of COPD in the UK primary-care setting: an analysis of real-life Prescribing Patterns. International Journal of COPD. 2014;9:889-905.
11. EMA (2015) Ultibro Breezhaler EU Summary of Product Characteristics. [Online] Revised 27 January 2015. Available at:http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_- Product_Information/human/002679/WC500151255.pdf [Accessed 16 March 2015].
12. EMA (2014). Seebri Breezhaler EU Summary of Product Characteristics. [Online] Revised 28 September 2012. Available at: https://www.medicines.org.uk/emc/medicine/27138/SPC/Seebri+Breezhaler+Inhalation+Powder,+Hard+Capsules+4 4mcg/%20 [Accessed 13 April 2015].
13. Pavkov et al. Characteristics of a capsule based dry powder inhaler for the delivery of indacaterol. CMRO 2010;26; 11:2527–2533. doi:10.1185/03007995.2010.518916.
14. Global Alliance Against Chronic Respiratory Diseases (GARD). 8th General Meeting. Available at: http://www.who.int/gard/publications/GARDGMreport2013.pdf. [Accessed 16 March 2015].
15. NIH NHLIB Chartbook 2012. Available at: https://www.nhlbi.nih.gov/files/docs/research/2012_ChartBook_508.pdf [Last accessed 21 April 2015]
16. World Health Organization: Chronic Obstructive Pulmonary Disease (COPD) Fact Sheet. Available at: http://www.who.int/respiratory/copd/burden/en/. [Accessed 16 March 2015]
17. National Vital Statistics Report (NVSR): Deaths: Final Data for 2012. Available at: http://www.cdc.gov/nchs/data/nvsr/nvsr63/nvsr63_09.pdf [Accessed 16 March 2015].
18. Joshi M, Joshi A, Bartter T. Symptom burden in chronic obstructive pulmonary disease and cancer. Curr Opin Pulm Med 2012;18:97-103.
19. DaCosta M et al. The burden of chronic obstructive pulmonary disease among employed adults. Int J Chron Obstruct Pulmon Dis 2012;7:211-219. Published online 2012 March 19. doi: 10.2147/COPD.S29280. [Accessed 16 March 2015].
20. 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.
 
 

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