RESEARCH TRIANGLE PARK, NC – The Food and Drug Administration has approved the first once-daily, inhaled corticosteroid/long-acting beta2 agonist (ICS/LABA) combination for the long-term, maintenance treatment of airflow obstruction in patients with COPD.
Fluticasone furoate and vilanterol inhalation powder, marketed as Breo Ellipta by GlaxoSmithKline in collaboration with Theravance, contains 100 micrograms fluticasone furoate and 25 micrograms vilanterol administered using Ellipta, a proprietary dry powder inhaler. It also is approved for the reduction of COPD exacerbations in patients with a history of those events.
“COPD is a serious disease that makes breathing difficult,” said Curtis Rosebraugh, MD, MPH, director, Office of Drug Evaluation II, Center for Drug Evaluation and Research at the FDA. “The availability of new long-term maintenance medications provides additional treatment options for the millions of Americans who suffer with COPD.”
FDA said the safety and efficacy of Breo Ellipta were evaluated in 7,700 COPD patients with those treated showing improved lung function and reduced exacerbations compared to placebo.
The drug is not approved for the treatment of asthma. In fact, Breo Ellipta carries a boxed warning that long-acting beta agonists increase the risk of asthma-related death.
It also should not be used as a rescue therapy to treat acute bronchospasm and is not recommended for people younger than 18 years, according to a patient medication guide that accompanies the prescription.
Increased risks of pneumonia and bone fractures are among the most serious side effects of using Breo Ellipta, according to the FDA, with the most common side effects including nasopharyngitis, upper respiratory tract infection, headache and oral candidiasis.