Approval of Ultibro Inhalation Capsules in Japan

Vectura Group plc confirms that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved Novartis' once-daily Ultibro Inhalation Capsules (glycopyrronium 50 mcg/indacaterol 110 mcg), delivered through the Breezhaler device, for relief of various symptoms due to airway obstruction in chronic obstructive pulmonary disease (COPD).

Ultibro Inhalation Capsules were developed under the name of QVA149 and will be available to the 5.3 million Japanese patients who may be living with COPD.⁴

Dual bronchodilation with QVA149 is expected to set a new standard of care in COPD by combining the proven efficacy and safety benefits of two established Novartis COPD treatments; the LABA*, Onbrez Inhalation Capsules (indacaterol), and the LAMA**, Seebri Inhalation Capsules (glycopyrronium bromide). Both these components are delivered through the Breezhaler device, as is QVA149, and are widely available in many countries around the world including Japan.

The efficacy and safety of QVA149 is supported by the comprehensive IGNITE Phase III clinical trial programme, one of the largest international trial programs in COPD comprising 11 studies in total with more than 10,000 patients from 52 countries.^1–3,5–14

In July, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for approval of QVA149. US submission is anticipated at the end of 2014.

Dr Chris Blackwell, Chief Executive of Vectura, commented: "The approval in Japan of QVA149, delivered through the Breezhaler device is an important first step towards making new treatment options available globally for patients with COPD. This innovative, once-daily therapy has the potential to reduce breathlessness and exacerbations, improve lung function and help improve overall quality of life. The approval of QVA149 in Japan further de-risks Vectura's business strategy and brings a new royalty stream from a first in class asset, as well as triggering a $2.5 million milestone to Vectura."

References

1. Bateman ED, Feruson GT, Barnes N et al. Dual bronchodilation with QVA149 versus single bronchodilator therapy: the SHINE study. European Respiratory Journal [Published on 30 May 2013].

2. Vogelmeier C et al. Efficacy and safety of once-daily QVA149 compared with twice-daily salmeterol/fluticasone in patients with COPD (ILLUMINATE): a randomised, double-blind, parallel group study. Lancet Respiratory Medicine. 2013;1(1): 51–60.

3. Wedzicha JA et al. Analysis of Chronic Obstructive Pulmonary Disease Exacerbations with the Dual Bronchodilator QVA149 Compared with Glycopyrronium and Tiotropium (SPARK): a Randomized, Double-blind, Parallel-group Study. Lancet Respiratory Medicine 2013;1(3): 199–209. 

4. Fukuchi, et al. The Nippon COPD Epidemiology (NICE) Study. Respirology 2004.

5. Beeh K et al. QVA149 once daily improves exercise tolerance and lung function in patients with COPD: the BRIGHT study. Thorax. 2012;67(2) A147.

6. Dahl R et al. Safety and efficacy of dual bronchodilation with QVA149 in COPD patients: the ENLIGHTEN study. Respiratory Medicine Journal 2013. 107:1558–1567.

7. Mahler D et al. Superior lung function with once-daily QVA149 translates into improvements in patient reported breathlessness compared with placebo and tiotropium in COPD patients: the BLAZE study. [ATS abstract 45308; Session C20; Date: 21 May 2013 Time: 8:15–10:45].

8. www.clinicaltrials.gov/ct2/show/NCT01285492?term=%28ARISE%29&rank=4

9. ClinicalTrials.gov, n.d. Comparison of Safety and Efficacy of the Combination Product QVA149A Against the Concurrent Administration of the Individual Components, QAB149 and NVA237, in Patients With Chronic Obstructive Pulmonary Disease (COPD) (BEACON).

10. ClinicalTrials.gov, n.d. Comparison of Long-term Safety of the Combination Product QVA149A Against Placebo and Standard of Care Treatment in Chronic Obstructive Pulmonary Disease Patients With Moderate to Severe Airflow Limitation (RADIATE).

11. ClinicalTrials.gov, n.d. A 26-week Treatment Randomized, Double-blind, Double Dummy, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of QVA149 (Indacaterol/Glycopyrronium Bromide) Compared to Fluticasone/Salmeterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease.

12. ClinicalTrial.gov, n.d. A 52-week Treatment, Multi-center, Randomized, Double-blind, Double Dummy, Parallel-group, Active Controlled Study to Compare the Effect of QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) With Salmeterol/Futicasone on the Rate of Exacerbations in Subjects With Moderate to Very Severe COPD (FLAME).

13.  www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-395_Spiriva.cfm

14.  www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021077_S003_ADVAIR_DISKUS.pdf