HealthDay News — The FDA has approved umeclidinium/vilanterol (Anoro Ellipta, GlaxoSmithKline) a new inhaled drug to treat chronic obstructive pulmonary disease (COPD).
The once-daily dry-powder inhaler is indicated for long-term maintenance of airflow in patients with COPD. This is the first fixed-dose combination of a long-acting beta agonist and a long-acting muscarinic antagonist (LABA/LAMA).
“The availability of new long-term maintenance medications provides additional treatment options for the millions of Americans who suffer with COPD,” Curtis Rosebraugh, MD, MPH, director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, said in a press release.
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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 umeclidinium/vilanterol included pharyngitis, sinusitis, lower respiratory tract infection, constipation, diarrhea, pain in extremities, muscle spasms, neck pain and chest pain. The drug can cause serious side effects including paradoxical bronchospasm, cardiovascular effects, acute narrow-angle glaucoma and worsening of urinary retention.
Umeclidinium/vilanterol is not approved for asthma treatment and should not be used as a rescue treatment for acute bronchospasm, the FDA said. The drug will carry a boxed warning that the class of drugs vilanterol belongs to increases the risk of asthma-related death.
