Novartis Ultibro Breezhaler approved by EC and Japan for treating COPD

26 September 2013

Novartis has announced it has gained EC approval for its once-daily Ultibro Breezhaler as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

In addition, the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Ultibro Inhalation Capsules, delivered through the Breezhaler device, for relief of various symptoms due to airway obstruction in chronic obstructive pulmonary disease (COPD).

"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," said David Epstein, Division Head, Novartis Pharmaceuticals. "Many COPD patients will now have a better treatment option, including first-line therapy with the launch of Ultibro Breezhaler in Europe."

Dual bronchodilation with QVA149 combines the proven efficacy benefits and safety profiles of two established Novartis COPD treatments: the LABA, Onbrez Breezhaler (indacaterol); and the LAMA, Seebri Breezhaler (glycopyrronium bromide). Both these components are delivered through the Breezhaler device, as is QVA149, and are widely available around the world.

"Since 2007, Novartis has received approvals for 15 new treatments and 16 new indications for existing treatments in Japan," said Timothy Wright, Global Head Development, Novartis Pharmaceuticals. "Japan plays a critical role in our global clinical research program. In the last five years, Novartis has conducted 175 clinical studies in Japan with over 14,000 patients."


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