FDA approves first once-daily dual bronchodilator for COPD

FDA approved umeclidinium and vilanterol inhalation powder (Anoro Ellipta, GlaxoSmithKline and Theravance) for the once-daily, long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

COPD is a serious lung disease that makes breathing difficult and 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, COPD is the third leading cause of death in the United States.

“The FDA approval of [Anoro Ellipta] offers another therapeutic option for individuals with COPD and the possibility of improved quality of life through effective treatment,” said  Abimbola Farinde, PharmD, MS, who serves on the faculty at Columbia Southern University, Orange Beach, Ala.

Anoro Ellipta is a combination of umeclidinium, an inhaled anticholinergic that affects the muscles around the large airways and stops the muscles from tightening, and vilanterol, a long-acting beta2-adrenergic agonist (LABA) that improves breathing by relaxing the muscles of the airways to allow more air to flow into and out of the lungs. The safety and efficacy of Anoro Ellipta were evaluated in more than 2,400 patients with COPD. Those treated showed improved lung function compared to placebo.

In a press release, Darrell Baker, senior vice president and head of the GSK Global Respiratory Franchise, said: “We believe Anoro Ellipta will be an important treatment option for appropriate patients with COPD. It is the first combination product approved in the U.S. that delivers two once-daily bronchodilators in a single inhaler. This approval is a significant achievement for GSK.”

The drug carries a boxed warning that LABAs increase the risk of asthma-related death. The safety and efficacy of Anoro Ellipta in patients with asthma have not been established. Anoro Ellipta is not indicated for the relief of acute bronchospasm or for the treatment of asthma.

A patient medication guide that includes instructions for use and information about the potential risks of taking the drug was approved with Anoro Ellipta.

Narrowing and obstruction of the respiratory airway (paradoxical bronchospasm), cardiovascular effects, increased pressure in the eyes (acute narrow-angle glaucoma), and worsening of urinary retention, are the serious side effects of taking Anoro Ellipta. Common side effects reported by patients using Anoro Ellipta included sore throat, sinus infection, lower respiratory tract infection, constipation, diarrhea, pain in extremity, muscle spasms, neck pain, and chest pain.