LONDON and SOUTH SAN FRANCISCO, Calif., May 10, 2013 /PRNewswire/ -- GlaxoSmithKline plc (LSE/NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the US Food and Drug Administration (FDA) has approved BREO™ ELLIPTA™ as an inhaled long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations.
BREO ELLIPTA is a combination of the inhaled corticosteroid (ICS), fluticasone furoate "FF", and the long-acting beta 2 agonist (LABA), vilanterol "VI" (FF/VI 100/25 mcg).
Darrell Baker, SVP & Head, GSK Global Respiratory Franchise, said, "This approval means that we can now realise our plan to bring BREO ELLIPTA to appropriate COPD patients in the US. We know that one of the main issues for patients who have experienced a COPD exacerbation is concern about possible future episodes. BREO ELLIPTA will help patients breathe better day-to-day and reduce the risk of future exacerbations, with a once-daily inhalation."
"The FDA approval of BREO ELLIPTA brings an important inhaled, once-daily maintenance therapeutic option to COPD patients and doctors across the United States," said Rick E Winningham, Chief Executive Officer of Theravance. "After more than a decade of joint respiratory research and development, the approval is a very important milestone for Theravance and GSK."Following this approval by the FDA, it is anticipated that BREO ELLIPTA will be available in the US during the third quarter of 2013. Under the terms of the 2002 LABA collaboration agreement, Theravance is obligated to make a milestone payment of $30 million (USD) to GSK following FDA approval of BREO ELLIPTA. The data submitted to the FDA to support the regulatory review of FF/VI included data from a comprehensive programme of non-clinical studies, 52 clinical pharmacology studies in 1,406 patients, and 11 clinical studies in 7,851 patients with COPD. There were four primary COPD studies: two 6-month lung-function studies and two 1-year replicate exacerbation studies.
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