FDA Approves GSK’s Anoro Ellipta, The First LABA/LAMA Combination

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.

GlaxoSmithKline PLC will launch Anoro Ellipta (umeclidinium/vilanterol) in the first quarter. The once-daily long-acting muscarinic antagonist (LAMA) and long-acting beta2-adrenergic agonist (LABA) was approved by FDA for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease Dec. 18.

The approval marks the first LAMA/LABA combination product to clear FDA and is a back-to-back win for GSK, which is...