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

GlaxoSmithKline Inc. and its development partner Innoviva Inc.’s Anoro Ellipta for chronic obstructive pulmonary disease received a largely favorable review from FDA ahead of its Sept. 10 advisory committee review. Cardiovascular safety appeared to be agency reviewers’ biggest concern, but even in this regard the agency questioned whether safety imbalances seen in clinical trials constitute a true safety signal.

The companies are seeking approval of Anoro Ellipta, a long-acting muscarinic antagonist (LAMA)/long-acting beta 2-adrenergic (LABA) combination of umeclidinium (UMEC) 62.5 mcg and vilanterol (VI) 25 mcg inhalation powder, for...