FDA approves Breo Ellipta, a new once-daily COPD inhaler treatment - PulmCCM
May 162013
FDA Approves Breo Ellipta, Once-Daily LABA/ICS for COPD

The FDA approved the new drug Breo Ellipta as a once-daily inhaled therapy for chronic obstructive pulmonary disease (COPD). Breo Ellipta includes the corticosteroid fluticasone, and vilanterol -- a once-daily long acting beta agonist -- in a combination dry powder inhaler. This was the FDA's first approval of the LABA vilanterol.

Breo Ellipta is GSK/Theravance's entry into the market of once-daily LABAs for COPD. Indacaterol was the first once-daily long-acting beta agonist, approved by FDA in 2011.

Breo Ellipta's approval was based on trials enrolling 7,700 patients, mostly with moderate or severe COPD. Breo Ellipta improved FEV1 by 173 mL and 209 mL compared to placebo in small trials enrolling 410 patients total. In other trials, the combination fluticasone/vilanterol product reduced moderate severe exacerbations by about 20%. Its ~35% reduction in severe exacerbations was not statistically significant.

The once-daily dosing of Breo Ellipta is predicted to improve patient adherence, although this wasn't tested in any of the trials.

The FDA's advisory committee had no problem recommending approval of Breo Ellipta last month, voting 9-4 for it, unconcerned by what seemed to be a low risk of pneumonia and bone fracture (known risks of inhaled corticosteroids). Like other LABA-containing drugs, Breo Ellipta will carry a black box warning regarding its use for asthma (for which it is not approved yet).

GSK and Theravance expect to have Breo Ellipta on sale in mid-late 2013. Approval in Europe and Japan should come soon, if things go GSK's way. Pricing has not been announced. Advair, a similar drug with broader indications including asthma, brought $7 billion in revenues for GSK in 2009 alone. Analysts predict Breo Ellipta will bring in $337 million next year.

GSK and Theravance have also submitted for FDA's review another combination product called Anoro that includes a once-daily muscarinic antagonist (like Spiriva) and a once-daily long acting beta agonist. FDA is expected to respond before the end of the year.

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  5 Responses to “FDA approves Breo Ellipta, a new once-daily COPD inhaler treatment”

  1. I wish generics were out there for inhalers for Seniors especially with SO MANY ($24 million) of us and many like me are non smokes are affected and need them to breath, even with insurance they are $50-$70 and for low income retirees that takes a big part of living expenses. A generic available for $3-10 would certainly help maintain other daily expenses.

  2. I agree. My copayment for advair is $85. I buy mine either Fromm Canada for $55. Or in Mexico for $40. I feel this is even too much

  3. I just wonder if this inhaler is like all of the rest I have not got a good thing to say about any of them but they do make the big wheels of there companies rich so the only thing that curies C-O-P-D is the undertaker and that is the fact JACK

  4. I agree with what everyone has said. While I am able to work I am sure it will come down to early retirement or total disability. Meaning fixed budget either way around. My health care provider wants me to make a decision on two inhalers, anorao ellipta or Breo Ellipta.

    what gets me is that everyone does studies and as my last doctor said, “asthma is an allergy”. well then I am allergic to everything and everyone in my environment . you ask politely for coworkers not to use perfume. you ask politely for a coworker to please remove the flowers she received and we are always told to wear a mask. The mask doesn’t do anything only impedes my breathing and still can smell the flowers that cause havoc with my breathing.

    I said all this to my physician and now I suppose to do research on what type of mask would be most beneficial. Please.

    now being affected by what is going around, loosing my appetite, loosing weight, becoming dehydrated and now I support them by accepting hospitalization? I agree with Dale in the only thing that cures C O P D is the undertaker.

    I had asthma as a young child which went away. It came back when exposed to Black Mold. and it won’t go away. I have told my physician and recommended to them for me to see a pulmologist but again I am side track with sayings asthma is an allergy. My grandmother (father’s mother) died of lung cancer. My mother died of lung cancer. do they really care besides seeing their pockets being filled with my hard earned money and my symptoms are not really taken care of?