Novartis receives approval in Japan for Onbrez® Inhalation Capsules

Novartis announced today that it has received regulatory approval in Japan for Onbrez® Inhalation Capsules (indacaterol) 150 mcg once-daily for the treatment of chronic obstructive pulmonary disease (COPD). Onbrez is the only once-daily COPD therapy to combine improvements in lung function lasting for 24 hours[1],[2],[3] with a rapid onset of action within five minutes of the first dose[4],[5].

“Indacaterol is a novel bronchodilator that offers a unique combination of fast- and long-acting properties,” said Senior Professor Atsushi Nagai of the First Department of Medicine at Tokyo Women’s Medical University. “In addition to the convenience of once-daily dosing, it has shown benefits in terms of reduced breathlessness and improved quality of life, and could provide a promising new treatment option for Japanese patients with COPD.”

Onbrez, delivered using the Breezhaler® device, belongs to the long-acting beta2-agonist (LABA) class of medicines which help to reduce the symptoms of breathlessness, cough and sputum in COPD patients by increasing bronchodilation, or airflow into the lungs. The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Onbrez for relief of symptoms due to airway obstruction in COPD (chronic bronchitis and emphysema).

The submission was supported by a clinical trial program that included three local clinical studies. The pivotal 12-week Phase III study was conducted in Japan and five other Asian countries and involved 347 patients with moderate-to-severe COPD[6]. This study showed that Onbrez given once-daily produced significant improvements in lung function (measured by trough FEV1, or forced expiratory volume of breath in one second) compared to placebo, as well as reducing breathlessness and improving quality of life[6]. The incidence of adverse events was lower than for placebo[6]. Altogether, these three studies involved a total of 388 Japanese patients.

“We are pleased that the health authorities in Japan have recognized the positive benefit-risk profile of Onbrez for patients suffering from this serious and life-threatening disease,” said David Epstein, Head of the Pharmaceuticals Division of Novartis. “Investing in Japan and building upon our leading presence is a key priority for us, and we welcome the fact that patients there will have access to this important medicine.”

COPD is a chronic, progressive lung disease that is commonly caused by tobacco smoking, air pollution or occupational exposure, and results in airflow obstruction and debilitating bouts of breathlessness. Although the latest figures show only 173,000 people have been diagnosed with COPD in Japan[8], epidemiological data suggest that the total number of patients could be as high as 5.3 million[7]. There are concerns that the number of patients could grow in Japan where smoking rates are high and many people are starting to smoke at an increasingly early age.

Indacaterol was first approved in November 2009 in the European Union under the brand-name Onbrez® Breezhaler® and has now been approved in more than 60 countries, including Turkey in May 2011. It is available in more than 30 countries with additional launches planned during 2011. In the US, the Food and Drug Administration (FDA) is expected to complete its review of the new drug application by July 2011. If approved in the US the brand name will be Arcapta(TM) Neohaler(TM).

References

1. Donohue JF, Fogarty C, Lötvall J, et al. Once-daily bronchodilators for chronic obstructive pulmonary disease: Indacaterol versus tiotropium. Am J Respir Crit Care Med 2010;182:155-162.
2. Dahl R, Chung KF, Buhl R, et al. Efficacy of a new once-daily long-acting inhaled beta2-agonist indacaterol versus twice-daily formoterol in COPD. Thorax 2010;65(6):473-9.
3. Kornmann O, Dahl R, Centanni S, et al. Once-daily indacaterol vs twice-daily salmeterol for COPD: a placebo-controlled comparison. Eur Respir J 2011;37:273-279.
4. Balint B, Watz H, Amos C, et al. Onset of action of indacaterol in patients with COPD: Comparison with salbutamol and salmeterol-fluticasone. Int J Chron Obstruct Pulmon Dis 2010;5:311-318.
5. Vogelmeier C, Ramos-Barbon D, Damon J, et al. Indacaterol provides 24-hour bronchodilation in COPD: a placebo-controlled blinded comparison with tiotropium. Respir Res 2010;11(1):135.
6. Kinoshita M, et al. Efficacy and safety of indacaterol 150 and 300 mcg in Asian COPD patients: A 12-week, placebo controlled study. Presented at American Thoracic Society (ATS) International Conference, Denver, Colorado, May 2011.
7. The Nippon COPD Epidemiology (NICE) Study – Fukuchi, et al. Respirology 2004.
8. 2008 Patient Study. Ministry of Health, Labor and Welfare.