Update on Ultibro® Breezhaler® and Seebri® Breezhaler® for COPD
Tokyo, Japan – 29 January 2014: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) confirms that an update on Ultibro® Breezhaler® (“Ultibro”) and Seebri® Breezhaler® (“Seebri”) has been provided as part of the Novartis AG FY2013 financial results announcement.
Key points from the announcement are as follow:
Following approvals in Europe and Japan, Ultibro has been approved by Health Canada as a long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
A Phase III clinical trial program has been initiated to evaluate once-daily NVA237 (development code for Seebri) in patients with uncontrolled asthma. Seebri has already been approved as a maintenance bronchodilator treatment for COPD in Europe, Japan, Canada and Australia.
US filing for both Seebri and Ultibro is expected in Q4 2014.
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