Once-daily Ultibro®* (QVA149) (glycopyrronium bromide/indacaterol maleate; Ultibro® Breezhaler® (EU), Ultibro® Inhalation Capsules (Japan)) is an inhaled, fixed-dose combination of the LAMA Seebri® (NVA237) that is licensed to Novartis, and the LABA Onbrez®, Novartis' own product. It has already been approved in the EU and Japan as a maintenance bronchodilator treatment for COPD.
In the US, QVA149 was approved in October 2015 as a twice-daily inhaled, fixed-dose combination of indacaterol 27.5 mcg and glycopyrrolate 15.6 mcg, for the long-term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema, and under the brand name Utibron™ Neohaler®.
Milestones and Royalty Revenue
Under the terms of the agreement with Novartis, Sosei is eligible to receive Ultibro® development milestones, as well as royalties on product sales.
- 17 Nov 2015
FLAME Study Shows Superiority of Ultibro Breezhaler over Seretide in Reducing COPD Exacerbations
- 30 Oct 2015
Sosei confirms FDA approvals of new dual combination bronchodilator Utibron Neohaler and monotherapy Seebri Neohaler for patients with chronic obstructive pulmonary disease
- 18 Jun 2015
Planned development of inhaled triple therapy QVM149 for asthma
- 21 May 2015
Two positive US phase III programs in COPD for QVA149 and NVA237
- 06 Mar 2015
U.S. FDA filing acceptance of NDAs for QVA149 and NVA237
- 08 Jan 2015
Sosei confirms the submission of regulatory applications to US FDA and robust Phase III results for QVA149 and NVA237
- 03 Dec 2014
Ultibro Breezhaler launched in the UK for the treatment of chronic obstructive pulmonary disease (COPD)
- 08 Sep 2014
Positive results from three clinical trials presented at ERS 2014 further confirmed efficacy of Ultibro Breezhaler and Seebri Breezhaler, and promotion agreement with Pfizer in the UK
- 21 May 2014
Positive results at ATS for once-daily Ultibro Breezhaler versus combination therapy (tiotropium plus formoterol)
- 30 Apr 2014
Once-daily Ultibro Breezhaler showed superior efficacy versus Seretide for COPD patients in second head-to-head study, and the anticipated timing of China filing
- 29 Jan 2014
Update on Ultibro Breezhaler and Seebri Breezhaler for COPD
- 20 Nov 2013
Once-daily Ultibro Inhalation Capsules (QVA149) for COPD launched in Japan
- 23 Sep 2013
First in class once-daily dual bronchodilator Ultibro Breezhaler (QVA149) approved for the treatment of COPD in Europe
- 20 Sep 2013
First in class once-daily dual bronchodilator Ultibro Inhalation Capsules (QVA149) approved for the treatment of COPD in Japan
- 09 Sep 2013
Data at ERS further demonstrates efficacy of once-daily Ultibro Breezhaler (QVA149) and Seebri Breezhaler (glycopyrronium bromide)
- 04 Sep 2013
QVA149 and glycopyrronium abstracts to be presented at ERS 2013
- 26 Aug 2013
First in class once-daily dual bronchodilator QVA149 gains endorsement for approval from Drug Committee of MHLW (Ministry of Health, Labour and Welfare) for the treatment of COPD in Japan
- 27 Jul 2013
First in class once-daily dual bronchodilator Ultibro Breezhaler (QVA149) gains positive CHMP opinion for the treatment of COPD
- 22 May 2013
New data reinforces strength of once-daily COPD portfolio in improving lung function, shortness of breath and reducing rate of exacerbations
- 24 Apr 2013
Seebri Breezhaler GLOW 5 and GLOW 6 Phase III studies meet primary endpoint, and data from QVA149 SPARK Phase III study published in a medical journal
- 07 Nov 2012
QVA149 filed by licensing partner as a once-daily maintenance treatment for COPD in Japan
COPD is a chronic obstruction of the airways caused by emphysema or chronic bronchitis induced primarily by smoking or air pollution.
According to a WHO survey, there were 210 million COPD patients worldwide in 2009, and in 2012, COPD became the third leading cause of death.
In 2013, the COPD market was estimated at around $13 billion. It is expected to increase still further in future, reaching $19 billion by 2019 as a result of better recognition of the disease and improved treatment options.
*Seebri® Breezhaler®／Seebri® Inhalation Capsules 50mcg, Onbrez® Breezhaler® ／Onbrez® Inhalation Capsules 150mcg, Ultibro® Breezhaler®／Ultibro® Inhalation Capsules are registered trademarks of Novartis AG.