GlaxoSmithKline (GSK) and Theravance have announced the FDA approval of Breo Ellipta as maintenance treatment of airflow obstruction in chronic obstructive pulmonary disease (COPD) patients.
The inhaled long-term, once-daily maintenance treatment is also indicated for the reduction of exacerbations in COPD patients with possible future episodes of exacerbations.
Breo Ellipta comprises inhaled corticosteroid (ICS), fluticasone furoate (FF), and the long-acting beta2 agonist (LABA), vilanterol (VI) (FF/VI 100/25 mcg).
GSK global respiratory franchise senior vice president and head Darrell Baker said patients who have experienced a COPD exacerbation will be concerned about the 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," Baker added.
Breo Ellipta is expected to be available in the US during the third quarter of 2013.
As per the 2002 LABA collaboration agreement signed between both the countries, the FDA approval triggers $30m milestone payment to GSK from Theravance.
Theravance chief executive officer Rick Winningham said, "The FDA approval of BREO ELLIPTA brings an important inhaled, once-daily maintenance therapeutic option to COPD patients and doctors across the United States."
