FDA Advisory Committee recommends approval in U.S. of umeclidinium/vilanterol for the treatment of COPD

September 10, 2013

GlaxoSmithKline and Theravance, Inc. today announced that the Pulmonary-Allergy Drugs Advisory Committee (PADAC) to the US Food and Drug Administration (FDA) recommends approval of umeclidinium/vilanterol (UMEC/VI) for the long-term, once-daily, maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).

ANORO™ ELLIPTA™ is the proposed proprietary name for UMEC/VI.

If approved, Anoro Ellipta will be the first, once-daily dual bronchodilator available in the U.S.

UMEC/VI is an investigational medicine and is not currently approved anywhere in the world.