Novartis receives CHMP recommendation for Ultibro Breezhaler

Novartis has announced that its first-in-class once-daily dual bronchodilator therapy Ultibro Breezhaler has been recommended for European approval.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has endorsed the therapy as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Developed under the name QVA149, Ultibro Breezhaler is a fixed-dose combination of the bronchodilators indacaterol and glycopyrronium and has been shown to significantly improve the rate of COPD exacerbations in clinical trials.

The European Commission is now expected to approve the therapy within three months.

David Epstein, division head at Novartis Pharmaceuticals, said: "QVA149 has shown significant improvements compared with some of the most commonly used treatment options for COPD, which is projected to be the third leading cause of death by 2020."

This comes in the same week that the CHMP also recommended Novartis' Ilaris as a therapy for systemic juvenile idiopathic arthritis.