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

Executive Summary

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.

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