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GSK’s Anoro Ellipta Heads To FDA Panel With Higher Hopes For Higher Dose

This article was originally published in The Pink Sheet Daily

Executive Summary

The lead LAMA/LABA combination for COPD will be reviewed at the Sept. 10 session of the Pulmonary-Allergy Drugs Advisory Committee.

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GSK Anoro Ellipta Appears Poised For Smooth Advisory Panel; Is First LAMA/LABA On Horizon?

Candidate for first-approved LAMA/LABA combination for COPD heads to the Pulmonary-Allergy Drugs Advisory Committee as FDA questions whether safety is even a concern.

Breo Inverts Traditional Path To COPD Indication For LABA Combinations

GlaxoSmithKline’s NDA for Breo Ellipta sought a COPD indication without prior approval of the combination product or its individual inhaled corticosteroid and long-acting beta agonist components in asthma. A broad development program with extensive dose finding won over a skeptical FDA.

GSK’s Breo Ellipta Approved With COPD Airflow Obstruction, Exacerbation Claims

Once-daily dosing provides a convenience advantage over the other inhaled corticosteroid/long-acting beta-agonist combination products on the COPD market: GlaxoSmithKline’s own Advair and AstraZeneca’s Symbicort.

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