Novartis’ Ultibro Breezhaler approved in EU and Japan

Novartis has announced that its new product Ultibro Breezhaler has been approved in Europe and Japan for the treatment of chronic obstructive pulmonary disease (COPD).

The European Commission has approved the once-daily therapy as a maintenance bronchodilator treatment to relieve symptoms in adult COPD patients, coinciding with a similarly positive ruling from Japan's ministry of health, labour and welfare.

In the pivotal phase III trial Ignite, Ultibro Breezhaler was shown to significantly improve lung function and patient-reported outcomes – including breathlessness and rescue medication use – compared to current standards of care.

The new therapy combines the proven benefits of the existing Novartis products Onbrez Breezhaler (indacaterol) and Seebri Breezhaler (glycopyrronium bromide) into a single product.

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

Novartis presented data showcasing the various advantages and strong safety performance of the drug at the recent European Respiratory Society annual meeting.