Novartis files NDA at FDA for Ultibro Breezhaler (QVA 149) to treat COPD.

Novartis has filed a new drug application (NDA) for QVA 149 (indacaterol/glycopyrronium bromide) to treat Chronic Obstructive Pulmonary Disease (COPD) the application is supported with evidence from the FLIGHT 1 and 2 studies which met their primary objectives demonstrating statistically significant and clinically meaningful improvements in lung function (FEV1 AUC0-12) at week 12, compared to indacaterol and glycopyrronium bromide in moderate-to-severe COPD patients.

Comment: NVA 237 is already marketed in Europe as Ultibro Breezhaler since September 2014.If approved by the FDA, the drug will compete with Anoro (umeclidinium + vilanterol) from GSK. Anoro Ellipta - with multi dose delivery Ellipta is the likely leader of combination therapy for COPD.

The Ultibro Breezhaler offers patients a substantial advantage with its once-daily dosing formulation.The once-daily formulation will encourage patients currently taking single-formulation LAMAs and LABAs to switch to this new formulation as they seek to simplify their treatment regimens, which is expected to improve compliance and therefore improve outcomes to therapy. UltiBro Breezhaler demonstrated in trials of superior efficacy to Advair which may encourage patients to shift from popular ICS/LABA inhalers to the Ultibro Breezhaler.