GlaxoSmithKline's Anoro Ellipta is meant to be used once a day for long-term maintenance of airflow in patients with COPD. The lung disease makes breathing difficult and worsens over time.
"Anoro Ellipta works by helping the muscles around the airways of the lungs stay relaxed to increase airflow in patients with COPD," Dr. Curtis Rosebraugh, director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research, said in an agency news release.
"The availability of new long-term maintenance medications provides additional treatment options for the millions of Americans who suffer with COPD," he added.
Dr. Len Horovitz, a pulmonary specialist at Lenox Hill Hospital in New York City, said the new medication is a "unique combination" of two drugs presently used for COPD. "It combines a drug similar to Spiriva and a [long-acting beta agonist] as found in Advair, he said. "There is no steroid in Anoro Ellipta."
According to the FDA, Anoro Ellipta combines umeclidinium, a drug that prevents muscles around the large airways from tightening, and vilanterol, which improves breathing by relaxing the muscles of the airways to allow more air to flow into and out of the lungs.
Another lung specialist, Dr. Charles Powell, called the approval a "promising development for patients with COPD," noting other countries already allow this type of medication.
"Combined long-acting bronchodilators are available in Europe. Now we have the first approved combined long-acting bronchodilator medication available in the U.S.," said Powell, who is chief of pulmonary, critical care and sleep medicine at the Mount Sinai - National Jewish Health Respiratory Institute in New York City.
"Combining two effective bronchodilators can result in improved lung function and medication compliance compared to traditional COPD inhaled medications," Powell said.
The FDA approval is based on findings from more than 2,400 people with COPD. The results showed that those who took the drug had greater improvements in lung function than those who took a placebo. The most common side effects reported by patients who took Anoro Ellipta included sore throat, sinus infection, lower respiratory tract infection, constipation, diarrhea, pain in extremities, muscle spasms, neck pain and chest pain.
Serious side effects that can be caused by the drug include narrowing and obstruction of the airway, cardiovascular effects, increased pressure in the eyes, and worsening of urinary retention.
Anoro Ellipta is not approved for asthma treatment and should not be used as a rescue treatment for sudden breathing problems, the FDA said. The drug carries a boxed warning that the class of drugs that vilanterol belongs to increases the risk of asthma-related death.
"Patients with COPD need to be seen and examined before determining the appropriate use of this drug, as with any medication," added Horovitz.
Cigarette smoking is the main contributor to COPD, which is the third leading cause of death in the United States. Symptoms can include chest tightness, chronic cough and excessive phlegm.
The U.S. National Heart, Lung, and Blood Institute has more about COPD.