FDA Approves Breo Ellipta to Treat Chronic Obstructive Pulmonary Disease (COPD)
May
10, 2013 -- The U.S. Food and Drug Administration today approved Breo
Ellipta (fluticasone furoate and vilanterol inhalation powder) for the
long-term, once-daily, maintenance treatment of airflow obstruction in
patients with chronic obstructive pulmonary disease (COPD), including
chronic bronchitis and/or emphysema. It is also approved to reduce
exacerbations of COPD in patients with a history of exacerbations.
COPD is a serious lung disease that worsens over time.
Symptoms can include chest tightness, chronic cough and excessive
phlegm. Cigarette smoking is the leading cause of COPD, according to the
National Heart, Lung, and Blood Institute, and COPD is the third
leading cause of death in the United States.
Breo Ellipta works by decreasing inflammation in the lungs and
helping the muscles around the airways of the lungs stay relaxed to
increase airflow and reduce exacerbations in patients with COPD.
“COPD is a serious disease that makes breathing difficult,” said
Curtis Rosebraugh, M.D., M.P.H., 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.”
Breo Ellipta is a combination of fluticasone furoate, an inhaled corticosteroid, and vilanterol, a long-acting beta2-adrenergic
agonist (LABA).
The safety and efficacy of Breo Ellipta were evaluated
in 7,700 patients with a clinical diagnosis of COPD. Those treated
showed improved lung function and reduced exacerbations compared to
placebo.
The drug carries a boxed warning that LABAs increase the risk of
asthma-related death.
The safety and efficacy of Breo Ellipta in
patients with asthma have not been established, and it is not approved
for the treatment of asthma.
The FDA approved Breo Ellipta with a patient medication guide that
includes instructions for use and information about the potential risks
of taking the drug. Breo Ellipta should not be used as a rescue therapy
to treat sudden breathing problems (acute bronchospasm) and is not
recommended for people younger than 18 years.
Breo Ellipta may cause serious side effects, including increased
risks of pneumonia and bone fractures.
The most common side effects
reported by patients using Breo Ellipta included inflammation of the
nasal passage (nasopharyngitis), upper respiratory tract infection,
headache, and oral candidiasis (thrush).
Breo Ellipta was developed by GlaxoSmithKline, Research Triangle
Park, N.C., in collaboration with San Francisco-based Theravance.
Source: FDA
Posted: May 2013
تعليقات
إرسال تعليق