New COPD drug approved by FDA: Better than available inhalers?

2013-05-12 12:25
New inhaler for COPD approved by FDA: What's in it and is it better?

The FDA has approved a new inhaler drug for treatment of COPD. The drug Breo Ellipta is a combination of two medications. Can the drug help patients breathe better compared to what is already available, and how much will it cost?

The drug is not anything new actually. One part of the medication include a synthetic corticosteroid known as fluticasone furoate that is currently marketed by the drug company GlaxoSmithKline as Veramyst in the United States

Fluticasone furoat is also prescribed nasally to treat allergic rhinitis or hay fever.

The other part of the drug to treat COPD or emphysema is what is known as a beta adrenergic agonist – vilanterol that is long acting.

Beta adrenergic agonists have many medical uses including treatment of asthma, heart failure and allergic reactions.

Another medication in its class is albuterol that most patients with COPD are already using either in their nebulizers or as an inhaler.

Like other inhalers, the drug can cause respirtatory infections and ‘thrush’ - an infection of the mouth that requires separate treatment.

According to the FDA press release, Breo Ellipta was approved to provide another option for patient with COPD and chronic bronchitis.

The corticosteroid part of the medication reduces inflammation in the airways. The beta adrenergic agonist keeps the airways relaxed making it easier for people with lung disease to breathe.

It is also important to know how to manage COPD that is a very serious illness for which there is no cure. There are lifestyle steps that you can take to manage chronic bronchitis and emphysema, one of which is exercise.

Serious side effects of the newly approved inhaler include bone fractures and higher risk of pneumonia. Patients with lung disease are already at high risk for pneumonia, making it important to report increased cough, fever, chest pain or other symptoms to your doctor.

The drug also carries a warning of the possibility of asthma related death. The drug is not approved for asthma treatment.

In trials, the drug was compared to placebo. Patients given the inhaler had fewer COPD flare-ups; 7700 patients with the disease were enrolled in the study.

The drug was approved in Europe last year and marketed as Relvar. Breo-Ellipta is being marketed by GlaxoSmithKline and Theravance.

The inhaler is causing a stir because it is expected to generate $559 million in sales by the year 2015.

The drug is the first combination once a day drug approved for COPD treatment. There is also some question about which of the two drugs in the inhaler produced the clinical results shown in the trials.

The medication may take some time to get to insurance formularies, given there are probably less expensive options that can be used individually. Newly approved drugs often have higher co-payments, making them unaffordable for patients on fixed SS incomes.

The FDA approval of Breo-Ellipta gives COPD patients another inhaler option, but whether the drug is affordable remains to be seen. No one knows the price yet. If your doctor prescribes the medication, you might want to be prepared for a high price - check your insurance formulary or call your insurance company for pricing. Know that there are options that may be less pricey and discuss those with your physician.

Source:
FDA.gov

Image credit: Wikimedia Commons

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