May 22, 2013
New Option Approved for Long-Term COPD Treatment

Research Triangle Park, NC—Some of the 27 million Americans with chronic obstructive pulmonary disease (COPD) may benefit from a new treatment option.

The FDA has approved the first once-daily inhaled corticosteroid/long-acting beta-2 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.

The manufacturer says the product is expected to be available to dispense in the United States by the third quarter of this year.

“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, FDA. “The availability of new long-term maintenance medications provides additional treatment options for the millions of Americans who suffer with COPD.”

The 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.

“This approval means that we can now realize our plan to bring Breo Ellipta to appropriate COPD patients in the U.S.,” said Darrell Baker, senior vice president and head of GSK Global Respiratory Franchise. “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.”

U.S. Pharmacist Social Connect