Novartis Ultibro Breezhaler approved by EC and Japan for treating
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."