New COPD drug approved by FDA

May 16th, 2013 | Author: Fabiana Talbot

The U.S. Food and Drug Administration (FDA) has approved Breo Ellipta (fluticasone furoate and vilanterol inhalation powder), a long-term, once-daily maintenance treatment of airflow obstruction in patients COPD! Developed by GlaxoSmithKline, Research Triangle Park, N.C., in collaboration with San Francisco-based Theravance, the treatment works by decreasing inflammation in the lungs and helping the muscles around the airways of the lungs stay relaxed to increase airflow and reduce exacerbations in patients with COPD.

“COPD is a serious, debilitating disease that makes breathing difficult,” says John W. Walsh, president and co-founder, COPD Foundation. “The availability of a long-term maintenance medication provides an additional treatment option for the estimated 24 million Americans living with COPD. We congratulate GlaxoSmithKline for developing Breo Ellipta, and anticipate that this new therapy will positively impact patient adherence to treatment regimens — and improve quality of life.”

Breo Ellipta is a combination of fluticasone furoate, an inhaled corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA). The safety and efficacy of Breo Ellipta were evaluated in 7,700 patients with a clinical diagnosis of COPD.

(fda.gov)

(fda.gov)

Those treated showed improved lung function and reduced exacerbations compared to placebo.

“For a disease suspected of impacting over 20 million Americans, we have struggled for far too long with a limited number of therapeutic options,” says Dr. Byron Thomashow, Clinical Professor of Medicine at Columbia University/New York Presbyterian Hospital and Chair of the COPD Foundations’ Board of Directors. “The recommendation of approval of this new once-daily agent is a very positive step forward. This is a unique agent; the first once daily combined inhaled steroid/long-acting beta agonist. And it’s important to note that the FDA has approved it both for maintenance and for preventing exacerbations. This drug will give us another excellent option for improving the lives of those living with COPD.”

The FDA approved Breo Ellipta with a medication guide that includes information about the potential risks. Breo Ellipta should not be used as a rescue therapy to treat acute bronchospasm, and is not recommended for people younger than 18 years.

“COPD is the third leading cause of death in the US, and yet we’ve seen far too few therapeutic options. This new drug approval represents a significant step forward,” says Dr. David Mannino, COPD Foundation Board Member and Professor in the Department of Preventative Medicine and Environmental Health at the University of Kentucky College of Public Health.
What are your thoughts on this new development??

9 comments

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  5. Susie Rosso Wolf says:

    Is this new drug an inhalation therapy drug used in a Nebulizer or is it another powder based drug like Advair Discus? If it’s an Advair type drug, I’d like to know if this is the “GENERIC” answer to Advair. THAT’S WHAT WE REALLY NEED! The long term once daily drugs are so expensive and many people go without them because they can’t afford it. If this is a generic Advair type medication, I say hats off and cheers. If not…I say, let’s get cracking on getting that done. Affordable, life saving, medications for COPD patients is long overdue.

  6. Kay says:

    Any idea how much this new drug costs? Will it be used instead of, rather than in addition to, nebulizer meds like perforomist, albuterol, etc.?

  7. Ralph Ackley says:

    will this take the place of muco-myst or will it be an adjunct to it.???

  8. Susan Thompson says:

    I have Medicare for my nebulizer medications, Part D for inhaled medications (and I’ve tried them all) , and it still runs me $500 per month, including my oxygen tank. I don’t qualify for portable oxygen for outside my home.

    Some of these inhaled medications have been on the market for so many years, (such as Advair), and have not made them any generic.

    For me, the inhaled medications all work about the same unless this is totally different. My nebulizer medications work better, along with Predisone when necessary, and oxygen.

    I would much rather see respiratory rehab programs from either a foundation or somewhere where it would be affordable. I feel that would help me so much, alongside my medications.

    Hope it works for a lot of people! Good luck.

  9. Heather says:

    I hope this drug is as great as they say it is and the side affects are not too great a cost for the reward. I’ve been on Advair 500/50 for years now and it does help but to have even less exacerbations would be great. I pray there will be a trial study in GA and I get called. Would love to see what it can do for me. But without health insurance I doubt I’ll have the luxury of getting to use this better med. My best to all involved in making it and all who are blessed with using it!

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