Novartis gains EU and Japan approval for COPD treatments

Swiss drug major Novartis (NOVN: VX) has received approval from the European Commission for once-daily Ultibro Breezhaler (indacaterol 85 mcg / glycopyrronium 43 mcg) as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

The Ultibro Inhalation Capsules (glycopyrronium 50 mcg / indacaterol 110 mcg), delivered through the Breezhaler device, has also been approved by the Japanese Ministry of Health, Labour and Welfare (MHLW). Both were developed under the name QVA149.

David Epstein, division head, Novartis Pharmaceuticals, said: “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.”