Just days after its approval in Japan, Novartis has announced that the Ultibro Breezhaler indacaterol/glycopyrronium (QVA149) DPI has been approved in Europe for the treatment of COPD. The approval triggers $10 million milestone payments to Sosei and Vectura.
Novartis Pharmaceuticals Division Head David Epstein commented, “We are very pleased that the European Commission and Japan approved QVA149, nearly simultaneously, for COPD patients. This rapid approval in Japan reflects our build-up of clinical trial and regulatory capabilities in Japan. Many COPD patients will now have a better treatment option, including first-line therapy with the launch of Ultibro Breezhaler in Europe.”
Vectura Chief Executive Chris Blackwell said, “The approval in Europe of QVA149, delivered through the Breezhaler device, is another important event for both Vectura and for patients with COPD. This innovative, once-daily therapy provides another option for patients to address unmet needs associated with their disease and improve their quality of life.”
Read the Novartis press release.
