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GSK, Theravance Launch Breo Ellipta

COPD treatment available in U.S.

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

GlaxoSmithKline and Theravance have launched Breo Ellipta, a once-daily prescription medicine for chronic obstructive pulmonary disease (COPD), in pharmacies throughout the U.S.

Breo Ellipta is a combination of the inhaled corticosteroid (ICS), fluticasone furoate “FF”, and the long-acting beta2-agonist (LABA), vilanterol “VI” (FF/VI 100/25 mcg). It is indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. Breo Ellipta is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. Breo Ellipta is NOT indicated for the relief of acute bronchospasm or for the treatment of asthma.

Under the terms of its 2002 LABA collaboration agreement with GSK, Theravance agreed to make a milestone payment of $30 million (USD) to GSK following the launch of Breo Ellipta in the U.S. The FDA approved Breo Ellipta on May 10, 2013.

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