Sosei confirms the submission of regulatory applications to US FDA and robust Phase III results for QVA149 and NVA237
Submissions to US FDA complete for QVA149 and NVA237 in Q4 2014
Pivotal Phase III results for QVA149 and NVA237 met their primary endpoints and significantly improved lung function in COPD patients1-5
US trials for QVA149 demonstrated significant improvements in overall health status compared to placebo1,2
Tokyo, Japan – 8 January 2015: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) confirms that the New Drug Applications (NDAs) for QVA149 and NVA237 for the long-term maintenance treatment of chronic obstructive pulmonary disease (COPD) was submitted to the US Food and Drug Administration (FDA) by Novartis in Q4 2014. Sosei is eligible to receive milestone payments upon the acceptance of applications by FDA.
In addition, the positive top-line results were announced today by Novartis from the pivotal Phase III clinical trial programs for QVA149 (indacaterol/glycopyrronium bromide) and NVA237 (glycopyrronium bromide) to support the application. The results from the EXPEDITION (including FLIGHT 1, 2 and 3 studies) and GEM (including GEM 1, 2 and 3 studies) clinical trial programs met their primary and secondary endpoints.
The FLIGHT 1 and 2 studies met their primary objectives with twice-daily QVA149 demonstrating statistically significant and clinically meaningful improvements in lung function (FEV1 AUC0-12) at Week 12, compared to indacaterol and glycopyrronium bromide in moderate-to-severe COPD patients1,2,9. Improvements in overall health status, a secondary endpoint based on the St George’s Respiratory Questionnaire (SGRQ) total score, and rescue medication usage were also seen with QVA149 compared to placebo at Week 121,2. The common adverse events reported for QVA149 were comparable to the individual components and placebo across the EXPEDITION studies1, 2.
In the GEM 1 and 2 studies, twice-daily NVA237 demonstrated significant and clinically meaningful improvements in lung function (FEV1 AUC0-12h) at Week 12 in moderate-to-severe COPD patients compared to placebo, meeting its primary objective4,5,9. An improvement in health status was also observed in patients at Week 12. The adverse events reported for NVA237 were comparable to placebo across the GEM studies4,5.
Data from the EXPEDITION and GEM programs are expected to be presented at major medical congresses later this year.
COPD symptoms can have a major negative impact on a patient’s ability to breathe and perform essential daily activities, thereby reducing their quality of life6,7. There is an urgent need for new treatment options in COPD because many patients remain symptomatic despite medical therapy8.
1. Clinicaltrials.gov. A 12 Week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation. (FLIGHT 1). CQVA149A2336. http://clinicaltrials.gov/ct2/show/NCT01727141?term=CQVA149A2336&rank=1 [Accessed 17 November 2014].
2. Clinicaltrials.gov. A 12-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation. (FLIGHT 2). CQVA149A2337. http://clinicaltrials.gov/ct2/show/NCT01712516?term=CQVA149A2337&rank=1 [Accessed 17 November 2014].
3. Clinicaltrials.gov. A Multi-centre Randomized Double Blind 52-week Study to Assess the Safety of QVA149 Compared to QAB in Patients With COPD Who Have Moderate to Severe Airflow Limitation. (FLIGHT 3). QVA149A2340. http://clinicaltrials.gov/ct2/show/NCT01682863?term=QVA149A2340&rank=1 [Accessed 17 November 2014].
4. Clinicaltrials.gov. NVA237 BID Versus Placebo Twelve-week Efficacy Study. (GEM 1). NVA237A2317. http://clinicaltrials.gov/ct2/show/NCT01709864?term=NVA237A2317&rank=1 [Accessed 17 November 2014].
5. Clinicaltrials.gov. NVA237 BID Versus Placebo Twelve-week Efficacy Study. (GEM 2). NVA237A2318. http://clinicaltrials.gov/ct2/show/NCT01715298?term=NVA237A2318&rank=1 [Accessed 17 November 2014].
6. World Health Organization: Chronic Obstructive Pulmonary Disease (COPD) Fact Sheet. http://www.who.int/mediacentre/factsheets/fs315/en/. [Accessed 09 December 2014].
7. Joshi M, Joshi A, Bartter T. Symptom burden in chronic obstructive pulmonary disease and cancer. Curr Opin Pulm Med 2012;18:97-103.
8. 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.
9. Donohue JF. Minimal clinically important differences in COPD lung function. COPD. 2005 Mar;2(1):111-24.
10. Ultibro Breezhaler EU Summary of Product Characteristics. [Online] 3 October 2013. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Information/human/002679/WC500151255.pdf [Accessed 23 July 2014].
11. EMA (2012). Seebri Breezhaler EU Summary of product characteristics. [Online] Revised 28 September 2012 http://www.medicines.org.uk/emc/medicine/27138/SPC/Seebri+Breezhaler+Inhalation+Powder,+Hard+Capsules+44 mcg/ [Accessed 1 August 2014].
12. Global Alliance Against Chronic Respiratory Diseases (GARD). 8th General Meeting. Available at: http://www.who.int/gard/publications/GARDGMreport2013.pdf. [Accessed on 17 November 2014].
13. World Health Organization: Chronic Obstructive Pulmonary Disease (COPD) Fact Sheet. http://www.who.int/respiratory/copd/en/ [Accessed 12 December 2014]
14. National Vital Statistics Report (NVSR): Deaths: Final Data for 2012. http://www.cdc.gov/nchs/data/nvsr/nvsr63/nvsr63_09.pdf. [Accessed 09 December 2014].
15. World Health Organization: Chronic Obstructive Pulmonary Disease (COPD) Fact Sheet. http://www.who.int/mediacentre/factsheets/fs310/en/ . [Accessed 09 December 2014]. 16. 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 17 November 2014].
17. 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.