GSK’s Breo Ellipta Marches Forward For Asthma, Efficacy Undistinguished From Advair
This article was originally published in Pharmaceutical Approvals Monthly
Follow-on may continue to face adoption challenges with expanded indication despite dosing convenience.
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Recent Phase III releases include data for Actavis’ ceftazidime/avibactam for gram-negative abdominal infections and Baxter’s long-acting Factor VIII hemophilia drug BAX 855. GSK’s fluticasone approved for asthma and Bristol/Pfizer’s Eliquis expands labeling.
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.
GSK reports positive results of a Phase III trial comparing the once-daily corticosteroid/long acting beta2-agonist combination Breo to the corticosteroid alone.