FDA Advisors Recommend Approval of Anoro Ellipta (Umeclidinium/Vilanterol) for Treatment of COPD
Final approval decision expected in December (September 10)
The FDA’s Pulmonary–Allergy Drugs Advisory Committee (PADAC) has voted 11 to 2 that the efficacy and safety data provide substantial evidence to support approval of umeclidinium/vilanterol (UMEC/VI, 62.5/25-mcg dose, GlaxoSmithKline/Theravance) 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.
The FDA Advisory Committee also voted that the safety of the investigational drug has been adequately demonstrated at the 62.5/25-mcg dose for the proposed indication (10 yes, 3 no), and that the efficacy data provided substantial evidence of a clinically meaningful benefit for UMEC/VI 62.5/25 mcg once daily for the long-term maintenance treatment of airflow obstruction in COPD (13 yes, 0 no).
The Prescription Drug User Fee Act (PDUFA) goal date for UMEC/VI is December 18, 2013.
Source: GSK; September 10, 2013.