GSK, Theravance submit investigational COPD treatment to FDA for review

LONDON and SOUTH SAN FRANCISCO, Calif. — GlaxoSmithKline and Theravance submitted a regulatory application to the Food and Drug Administration for their chronic obstructive pulmonary disease treatment.

The drug makers said they filed a new drug application for the once-daily investigational medicine fluticasone furoate/vilanterol (FF/VI), which touts the proposed brand name Breo. Breo, administered by the new Ellipta dry powder inhaler, is indicated for the long-term once-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema, and to reduce exacerbations of COPD in patients with a history of exacerbations. Breo will be available in the 100/25mcg strength.

GSK and Theravance also submitted a regulatory application for the drug to the European Union as a treatment for COPD and asthma.

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