GSK’s Anoro Ellipta Heads To FDA Panel With Higher Hopes For Higher Dose
This article was originally published in The Pink Sheet Daily
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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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.
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.
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.