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