GlaxoSmithKline plc and Theravance Inc received approval from the US Food and Drug Administration for their new COPD treatment, BREO ELLIPTA, a combination of the inhaled corticosteroid (ICS), fluticasone furoate "FF", and the long-acting beta2 agonist (LABA), vilanterol "VI" (FF/VI 100/25 mcg).
The product is an inhaled long-term, once-daily treatment for airflow obstruction in COPD patients, including chronic bronchitis and/or emphysema, according to GlaxoSmithKline. BREO ELLIPTA is also indicated to reduce COPD exacerbations in patients with a history of them.
"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," said Darrell Baker, senior vice president and head of GSK Global Respiratory Franchise.
The data submitted to the FDA to support the regulatory review of FF/VI included data from a comprehensive program 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, according to GSK, which partnered with Theravance Inc to develop the drug.
"After more than a decade of joint respiratory research and development, the approval is a very important milestone for Theravance and GSK," said Rick E Winningham, CEO of Theravance. "The FDA approval of BREO ELLIPTA brings an important inhaled, once-daily maintenance therapeutic option to COPD patients and doctors across the United States."
The companies anticipate that BREO ELLIPTA will be available in the US during the third quarter of 2013.
Important safety information and full US prescribing information, including BOXED WARNING and Medication Guide will be available soon on the GlaxoSmithKline US website.