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Clinical Research: COPD Study

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Clinical Research: COPD Study

Florida Lung Doctors Clinical Research COPD Study Announcement

This information was recently published by the FDA, concerning a COPD treatment that gained official approval.

Issued: FDA Advisory Committee recommends approval of BREO(TM) ELLIPTA(TM) for the treatment of COPD

Issued: Wednesday 17 April 2013, London UK and South San Francisco, CA, USA

GlaxoSmithKline plc (LSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the Pulmonary-Allergy Drugs Advisory Committee (PADAC) to the US Food and Drug Administration (FDA) voted that the efficacy and safety data provide substantial evidence to support approval of BREO™ ELLIPTA™ as a once-daily inhaled treatment for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) (9 for, 4 against) and also for the reduction of COPD exacerbations in patients with a history of exacerbations (9 for, 4 against)*.

BREO™ ELLIPTA™, is the proposed proprietary name for FF/VI 100/25 mcg, a combination of the inhaled corticosteroid (ICS) fluticasone furoate “FF” and the long acting bronchodilator (LABA) vilanterol “VI” (FF/VI).

The FDA Advisory Committee also voted that the safety of FF/VI 100/25 mcg once daily in COPD has been adequately demonstrated for the proposed indications (10 for, 3 against).

Wednesday 17 April 2013, London UK and South San Francisco, CA, USA

GlaxoSmithKline plc (LSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the Pulmonary-Allergy Drugs Advisory Committee (PADAC) to the US Food and Drug Administration (FDA) voted that the efficacy and safety data provide substantial evidence to support approval of BREO™ ELLIPTA™ as a once-daily inhaled treatment for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) (9 for, 4 against) and also for the reduction of COPD exacerbations in patients with a history of exacerbations (9 for, 4 against)*.

BREO™ ELLIPTA™, is the proposed proprietary name for FF/VI 100/25 mcg, a combination of the inhaled corticosteroid (ICS) fluticasone furoate “FF” and the long acting bronchodilator (LABA) vilanterol “VI” (FF/VI).

The FDA Advisory Committee also voted that the safety of FF/VI 100/25 mcg once daily in COPD has been adequately demonstrated for the proposed indications (10 for, 3 against).