GlaxoSmithKline plc GSK and Theravance, Inc.
THRX today announced that the Pulmonary-Allergy Drugs
Advisory Committee (PADAC) to the US Food and Drug Administration
(FDA) voted 11 yes to 2 no that the efficacy and safety data provide
substantial evidence to support approval of umeclidinium/vilanterol
(UMEC/VI, 62.5/25mcg dose) 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(TM) ELLIPTA(TM) 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(TM) inhaler.
The FDA Advisory Committee also voted that the safety of the
investigational medicine has been adequately demonstrated at the
62.5/25mcg dose for the proposed indication (10 yes, 3 no), and the
efficacy data provided substantial evidence of a clinically
meaningful benefit for UMEC/VI 62.5/25mcg once daily for the
long-term, maintenance treatment of airflow obstruction in COPD (13
yes, 0 no).
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