As expected, the US Food and Drug Administration has given the green light to GlaxoSmithKline and Theravance's Breo Ellipta for chronic obstructive pulmonary disease.
The approval comes just shy of a month after the agency's Pulmonary-Allergy Drugs Advisory Committee voted in favour of Breo Ellipta (fluticasone furoate/vilanterol) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. The inhaled treatment is also approved to reduce exacerbations of COPD in patients with a history of them.
Curtis Rosebraugh, director of the Office of Drug Evaluation II, Center for Drug Evaluation and Research at the FDA, said that "the availability of new long-term maintenance medications provides additional treatment options for the millions of Americans who suffer with COPD". The drug carries a boxed warning that long-acting beta-agonists (ie fluticasone) increase the risk of asthma-related death and Breo Ellipta should not be used as a rescue therapy to treat sudden breathing problems.
The drug will be available in the USA during the third quarter and as part of their collaboration, Theravance will make a $30 milestone payment to GSK. Breo Ellipta is the follow-up to GSK's own twice-daily Advair (salmeterol/fluticasone), which is approved for asthma as well as COPD, and it will also compete with AstraZeneca twice-a-day Symbicort (budesonide/formoterol).