Tokyo, Japan – 20 November 2013: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) confirms that Novartis Pharma K.K. launched once-daily Ultibro® Inhalation Capsules (“Ultibro®”; glycopyrronium / indacaterol), for relief of various symptoms due to airway obstruction in chronic obstructive pulmonary disease (COPD). Ultibro® was developed by Novartis under the name of QVA149.
Dual bronchodilation with Ultibro® is expected to set a new standard of care in COPD by combining the proven efficacy benefits and safety profiles of two established Novartis COPD treatments, the LABA*, Onbrez® Inhalation Capsules (indacaterol), and the LAMA**, Seebri® Inhalation Capsules (glycopyrronium bromide). All Novartis inhaled COPD portfolio products are developed for delivery via a single-dose dry powder inhaler (SDDPI) called the Breezhaler® inhalation device which has low air flow resistance, making it suitable for patients with airflow limitation1. The Breezhaler® device allows patients to hear, feel and see that they have taken the full dose correctly.
Ultibro® was approved in Japan and EU (under the brand name Ultibro® Breezhaler®) in September, and has since been launched in Germany and Netherlands. US submission is anticipated in the second half of 2014.
Ultibro®, Seebri®, Onbrez® and Breezhaler® are registered trademarks of Novartis AG.
* a long-acting beta2-adrenergic agonist,
** a long-acting muscarinic antagonist
1. Patient Study 2008. Ministry of Health, Labor and Welfare
2. Patient Study 2011. Ministry of Health, Labor and Welfare
3. Fukuchi, et al. The Nippon COPD Epidemiology (NICE) Study. Respirology 2004.