Anoro Ellipta Approved for COPD
WEDNESDAY, Dec. 18, 2013 -- Anoro Ellipta (umeclidinium and vilanterol inhalation powder) has been approved by the U.S. Food and Drug Administration for once-daily treatment of chronic obstructive pulmonary disease (COPD).
COPD, an umbrella term that includes the lung diseases bronchitis and emphysema, is a progressive condition that interferes with breathing. Symptoms may include chest tightness, chronic cough and overproduction of phlegm. It's the third-leading cause of death in the United States, the FDA said in a news release.
Anoro Ellipta, a combination of two approved medications, relaxes the lung airways to help breathing. The drug's safety and effectiveness were evaluated in clinical trials involving more than 2,400 people diagnosed with COPD.
The drug's label includes a warning that users have an increased risk of asthma-related death. However, the medication has not been evaluated in people with asthma, nor should it be taken as a treatment for asthma or for sudden breathing problems, the agency stressed.
Potential serious side effects of the new drug include narrowing of the respiratory airways, cardiovascular problems, glaucoma and worsening urinary retention. The most common side effects include sore throat, sinus infection, respiratory tract infection, constipation, diarrhea, extremity pain and muscle spasms.
Anoro Ellipta is produced by GlaxoSmithKline, based in Research Triangle Park, N.C.
The U.S. National Library of Medicine has more about COPD.
Posted: December 2013