Novartis Once-Daily COPD Combo Safe, Effective And Ready For Filing – Everywhere But In The U.S.
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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EXPEDITION clinical program seems to satisfy U.S. requirements for firm’s COPD bronchodilators; now all Novartis needs is approval, some clinical differentiation – and perhaps a marketing partner.
News that Forest/Almirall’s LABA/LAMA combination will be delayed due to a manufacturing issue means that GlaxoSmithKline’s Anoro Ellipta will continue to dominate the market as the sole fixed-dose combination available in the U.S.
FDA approved GSK’s Anoro Ellipta as the first LABA/LAMA combination product in the U.S. for the maintenance treatment of COPD Dec. 18, positioning GSK to launch a second respiratory product months after launching Breo Ellipta.