FDA Approves New COPD Drug
A new drug to treat chronic obstructive pulmonary disease (COPD) has been approved by the U.S. Food and Drug Administration (FDA).
READ: What Is COPD?
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GlaxoSmithKline’s Anoro Ellipta is meant to be used once a day for long-term maintenance of airflow in patients with COPD, which is a lung disease that makes breathing difficult.
“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.
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.
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.