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.

  • The Top 5 Safety and Technology Trends to Watch in 2019

    Get the latest on trends you can expect to hear more about in 2019, including continued growth of mobile safety applications, wearable technology, and smart PPE; autonomous vehicles; pending OSHA recordkeeping rulemaking; and increased adoption of international safety standard, ISO 45001.

  • Get the Ultimate Guide to OSHA Recordkeeping

    OSHA’s Form 300A posting deadline is February 1! Are you prepared? To help answer your key recordkeeping questions, IndustrySafe put together this guide with critical compliance information.

  • Safety Training 101

    When it comes to safety training, no matter the industry, there are always questions regarding requirements and certifications. We’ve put together a guide on key safety training topics, requirements for certifications, and answers to common training questions.

  • Conduct EHS Inspections and Audits

    Record and manage your organization’s inspection data with IndustrySafe’s Inspections module. IndustrySafe’s pre-built forms and checklists may be used as is, or can be customized to better suit the needs of your organization.

  • Industry Safe

OH&S Digital Edition

  • OHS Magazine Digital Edition - January 2019

    January 2019

    Featuring:

    • PREVENTING ERRORS
      Production vs. Safety 
    • EMERGENCY SHOWERS & EYEWASH
      Meeting the Requirements for Emergency Equipment
    • CONSTRUCTION SAFETY
      The State of Contractor Safety
    • FOOT PROTECTION
      The Three Keys to Effective Chemical Management
    View This Issue