Novartis' Ultibro Breezhaler shows superior efficacy over Seretide in COPD

Swiss drug major Novartis (NOVN: VX) today announced positive first results from the Phase III head-to-head LANTERN study which showed the superiority of once-daily Ultibro Breezhaler (indacaterol/glycopyrronium) in improving lung function in chronic obstructive pulmonary disease (COPD) patients.

The primary objective of the LANTERN study was to demonstrate the non-inferiority of Ultibro Breezhaler to GlaxoSmithKline’s Seretide Accuhaler (salmeterol/fluticasone) – SFC – in terms of lung function (trough FEV1) after 26 weeks of treatment in patients with moderate-to-severe COPD, with or without a history of moderate-to-severe exacerbations in the previous year. Ultibro Breezhaler demonstrated non-inferiority and additionally showed superior efficacy versus SFC for the primary objective. The LANTERN study also showed superiority of Ultibro Breezhaler compared to SFC for the key secondary objective of lung function (FEV1 AUC0-4h) over the first four hours post dose at week 26. The safety and tolerability profile of Ultibro Breezhaler was comparable to SFC.

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