Theravance confirms FDA panel recommends approval of Theravance-Glaxo lung drug

theflyonthewall.com

Theravance (THRX) and GlaxoSmithKline (GSK) announced that the Pulmonary-Allergy Drugs Advisory Committee to the FDA voted 11 yes to 2 no that the efficacy and safety data provide substantial evidence to support approval of Umeclidinium/Vilanterol for the long-term, once-daily, maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, or COPD, including chronic bronchitis and emphysema. 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, 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.

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