The Pulmonary-Allergy Drugs Advisory Committee (PADAC) of the US Food and Drug Administration (FDA) has recommended the approval of GlaxoSmithKline (GSK) and Theravance's umeclidinium/vilanterol as a treatment for chronic obstructive pulmonary disease (COPD).
The FDA's PADAC voted 11 to 2 that the efficacy and safety data provide substantial evidence to support approval of umeclidinium/vilanterol, for long-term treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema.
If approved, Anoro Ellipta, which is the proposed proprietary name for UMEC/VI, will be the first once-daily dual bronchodilator available in the US.
Anoro is a combination of umeclidinium bromide (UMEC), a long-acting muscarinic antagonist (LAMA) and vilanterol, a long-acting beta agonist (LABA), used with GSK's Ellipta inhaler.
PADAC also voted that the safety of the investigational medicine has been demonstrated at the 62.5/25mcg dose for the proposed indication.
The safety and efficacy data provide substantial evidence to support regulatory clearance of the treatment for chronic obstructive pulmonary disorder, according to the FDA's PADAC.
The FDA is expected to decide whether to approve UMEC/VI, the combination treatment by Prescription Drug User Fee Act (PDUFA) goal date 18 December 2013.
