FDA advisory panel gives thumbs up for Anoro Ellipta approval

There was a bit of good news for UK pharma giant GlaxoSmithKline yesterday (LSE: GSK) and partner USA-based Theravance (Nasdaq: THRX) when the US Food and Drug Administration’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted 11 for, to two against, that the efficacy and safety data provide substantial evidence to support approval of umeclidinium/vilanterol (UMEC/VI, 62.5/25mcg dose) for the long-term, once-daily, maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Anoro Ellipta is the proposed proprietary name for UMEC/VI, a combination of two investigational bronchodilator molecules - GSK573719 or umeclidinium bromide (UMEC), a long-acting muscarinic antagonist (LAMA) and vilanterol (VI), a long-acting beta2 agonist (LABA), administered using the Ellipta inhaler.

Sales could reach $2 billion a year in 2018