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Novartis Once-Daily COPD Combo Safe, Effective And Ready For Filing – Everywhere But In The U.S.

 
• By Shirley Haley

Novartis released results from “an unprecedented package of data” to be filed with European regulators for its novel once-daily dual bronchodilator combination of the LABA indacaterol and the LAMA NVA237 (glycopyrronium) for COPD at the European Respiratory Society Congress, but FDA has already made clear that it wants to see trials with once- and twice-daily dosing at lower strengths than those tried in the European program, and those studies have yet to launch.

Novartis AG introduced impressive data on its once-daily fixed dose indacaterol and glycopyrronium combination (QVA149) for chronic obstructive pulmonary disease at the European Respiratory Society Congress, including the tantalizing report that the combo bested GlaxoSmithKline PLC’s Advair, but the results must be repeated to meet registration requirements in the U.S.

While the data presented at ERS in Vienna Sept. 1-5 will be the basis of the European registration package, the...

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