GlaxoSmithKline and Theravance announced that the Pulmonary-Allergy Drugs Advisory Committee (PADAC) recommended approval to the FDA of Anoro Ellipta (umeclidinium/vilanterol) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
The PADAC voted 11 “yes” to 2 “no” supporting that the efficacy and safety data provide substantial evidence for product approval. The Advisory Committee voted that the safety of the investigational medicine has been adequately demonstrated at the 62.5mcg/25mcg dose for the proposed indication (10 yes, 3 no), and that the efficacy data provided substantial evidence of a clinically meaningful benefit for the long-term maintenance treatment of airflow obstruction in COPD (13 yes, 0 no).
Anoro Ellipta combines two investigational bronchodilators, umeclidinium bromide, a long-acting muscarinic antagonist, and vilanterol, a long-acting beta2 agonist, administered via the Ellipta inhaler.
The NDA was submitted in December 2012, and the final approval decision is made by the FDA taking into consideration the non-binding recommendations made by the Advisory Committee. The Prescription Drug User Fee Act goal date for Anoro Ellipta is December 18, 2013.