GlaxoSmithKline's Anoro Ellipta drug has been approved by the U.S. Food and Drug Administration to treat a serious lung condition called chronic obstructive pulmonary disease (COPD).
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.
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