FDA Approves COPD Medication

Breo Ellipta has been approved for long-term, once-daily maintenance treatment of airflow obstruction in patients.

The U.S. Food and Drug Administration has approved Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) for long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.

COPD is a serious lung disease that worsens over time. Symptoms can include chest tightness, chronic cough, and excessive phlegm. Smoking is the leading cause of COPD, according to the National Heart, Lung, and Blood Institute, and COPD is the third-leading cause of death in the United States.

Breo Ellipta decreases inflammation in the lungs and helps muscles around the airways of the lungs stay relaxed to increase airflow. "COPD is a serious disease that makes breathing difficult," said Dr. Curtis Rosebraugh, M.D., MPH, director of Office of Drug Evaluation II in FDA's Center for Drug Evaluation and Research. "The availability of new, long-term maintenance medications provides additional treatment options for the millions of Americans who suffer with COPD."

According to FDA, Breo Ellipta's safety and efficacy were evaluated in 7,700 patients diagnosed with COPD. Its safety and efficacy in patients with asthma have not been established, and it is not approved for the treatment of asthma. It may cause serious side effects, including increased risks of pneumonia and bone fractures. The most common side effects reported by patients using Breo Ellipta include inflammation of the nasal passage, upper respiratory tract infection, headache, and oral candidiasis (thrush). Breo Ellipta was developed by GlaxoSmithKline, Research Triangle Park, N.C., in collaboration with San Francisco-based Theravance.

Download Center

HTML - No Current Item Deck
  • Free Safety Management Software Demo

    IndustrySafe Safety Management Software helps organizations to improve safety by providing a comprehensive toolset of software modules to help businesses identify trouble spots; reduce claims, lost days, OSHA fines; and more.

  • Complete Online Safety Training Courses

    Deliver state-of-the art, online safety training courses to your organization with IndustrySafe Training Management Software. Generate reports to track training compliance and automatically notify learners of upcoming or overdue classes.

  • Easy to Use Safety Inspection App

    Conduct inspections on the go with IndustrySafe’s mobile app. Complete safety audits at job sites and remote locations—with or without web access.

  • Track Key Safety Performance Indicators

    IndustrySafe’s Dashboard Module allows organizations to easily track safety KPIs and metrics. Gain increased visibility into your business’ operations and safety data.

  • Analyze Incident Data and Maintain OSHA Compliance

    Collect relevant incident data, analyze trends, and generate accurate regulatory reports, including OSHA 300, 300A, and 301 logs, through IndustrySafe’s extensive incident reporting and investigation module.

  • Industry Safe
comments powered by Disqus