Novartis Reports Positive Ultibro Phase III Study Results For COPD

Novartis announced positive first results from the Phase III head to head LANTERN study. The study was comparing how once-daily Ultibro Breezhaler (indacaterol/glycopyrronium) improved lung function compared to twice-daily Seretide Accuhaler (salmeterol/fluticasone (SFC)) in patients with chronic obstruction pulmonary disease (COPD) with or without a history of moderate to severe exacerbations in the previous year. The trial met its primary and secondary endpoints, demonstrating Ultibro Breezhaler’s superiority over Seretide.

LANTERN’s primary objective was to demonstrate non-inferiority of the drug to SFC in terms of lung function after 26 weeks of treatment. “This is the second time Ultibro Breezhaler has shown superiority in improving lung function to Seretide in a head-to-head study and confirms benefits beyond this current standard of care. Such promising data will be part of a regulatory submission in China later this year and is exciting news for the COPD community and ultimately patients,” said Tim Wright, Global Head of Development of Novartis Pharmaceuticals.

Chronic obstructive pulmonary disease (COPD) is a life-threatening disease that hampers breathing with symptoms that limit activity and decrease patient mobility. COPD is estimated to affect 210 million people around the world and is projected to be the third leading cause of death by 2020.

Ultibro Breezhaler is a novel, once-daily dual bronchodilator approved in the EU as maintenance treatment for COPD symptom relief. The drug is licensed for use in more than 30 countries including Japan, Canada, Australia, and the E.U.

The drug was evaluated in the randomized, parallel-group, double-blind, 26 week LANTEN study. LANTERN was conducted at 56 sites across China, Chile, Argentina, and Taiwan. The study enrolled 741 patients and showed that Ultibro Breezhaler achieved superior lung function in patients compared with the Accuhaler dry powder inhaler. The safety and tolerability profile of Ultibro Breezhaler was reported to be comparable to salmeterol/fluticasone (SFC).