Thursday, August 29, 2013

Novartis and Sosei - QVA149 gets favorable recommendation for approval in Japan

Sosei Group Corporation has confirmed that the Drug Committee of MHLW has endorsed approval of once-daily QVA149 (glycopyrronium / indacaterol), developed by Novartis, as a treatment to relieve symptoms due to airway obstruction in chronic obstructive pulmonary disease (COPD) in Japan. The Japanese MHLW is expected to follow with approval in due course.

In July 2013, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the approval of QVA149 in Europe under the brand name Ultibro® Breezhaler®. Ultibro ® and Breezhaler® are registered trademarks of Novartis AG.

QVA149 is Partnered with Vectura and worldwide rights are exclusivel y licensed to Novartis.


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