COPD Med Closer to Pharmacy Shelves

COPD medication Breo recommended for approval by FDA panel

(RxWiki News) For patients with chronic obstructive pulmonary disease (COPD), breathing can become a difficult task. Once diagnosed, many COPD patients are treated with medications. And now these patients soon may have another treatment option.

An advisory committee to the US Food and Drug Administration (FDA) has recommended approval of Breo Ellipta, a once-daily inhaled treatment for COPD.

The advisory committee voted 9 to 4 in favor of approving the experimental medication based on evidence supporting its safety and effectiveness.

Although the FDA is not required to follow advisory panel recommendations, it usually does so.

"Ask your pharmacist about new COPD medications."

The FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) recommended approval of Breo not only for the long-term treatment of airway obstruction in patients with COPD, but also to reduce exacerbations of COPD.

A COPD exacerbation is the sudden worsening of COPD symptoms, which can include an increased shortness of breath and change in the amount and color of sputum (mucous).

Breo, as delivered through the Ellipta inhaler, is the proposed brand name for FF/VI 100/25 mcg, which is a combination of a corticosteroid called fluticasone furoate (FF) and a long-acting bronchodilator called vilanterol (VI). Bronchodilators widen the airways known as the bronchi and bronchioles.

The medication is made by GlaxoSmithKline Plc and Theravance, Inc.

In July 2012, these pharmaceutical companies submitted a New Drug Application for Breo to the FDA. The advisory panel's recommendation brings the medication one step closer to approval.

"We are pleased with the outcome of today's meeting," said Patrick Vallance, GlaxoSmithKline's President of Pharmaceuticals, R&D, in a press release.

"COPD is a debilitating and progressive disease. Its symptoms are often severe and can have a huge impact on patients' lives. This positive recommendation is a crucial first step towards making Breo Ellipta available for appropriate COPD patients across the US. We look forward to a final decision from the FDA later this year," Vallance said.

Jasan Poquette, RPh, of the Massachusetts Pharmacists Association, also anticipates approval of Breo.

“The favorable recommendation by the advisory panel of GlaxoSmithKline’s combination corticosteroid/beta agonist inhaler, Breo, is good news for COPD patients," Poquette told dailyRx News.

"As a progressive disease, COPD often becomes increasingly difficult to manage over time. Early treatment may simply involve lifestyle changes, such as quitting smoking or reducing exposure to other airborne pollutants.  But most patients eventually need to be treated with medications which may include oral steroids (like prednisone), inhaled bronchodilators (such as albuterol) and eventually inhaled steroids (fluticasone, mometasone or budesonide for example)," Poquette explained.

"The combination of an inhaled bronchodilator (which works by causing airway expansion) and an inhaled steroid (which reduces airway inflammation) is often necessary to treat patients with a history of COPD exacerbations. Breo offers such a combination," he said.

"The long-acting formulation, due to the novel beta-agonist vilanterol, will provide patients with the first once-daily inhaled product of this type. A once-daily approach helps improve compliance and offers greater freedom to COPD patients seeking to manage their disease while maintaining active, normal lives,” he said.

Studies have shown that the safety profile of Breo was generally consistent with other similar medications. In the four main COPD studies on Breo, the most commonly reported harmful side effects included nasopharyngitis (common cold), headache, upper respiratory tract infection, oropharyngeal candidiasis (a fungal infection known as thrush), back pain, pneumonia, bronchitis and sinus infection.

The most serious reported side effect was COPD exacerbation, followed by pneumonia.

Even though the advisory committee has recommended approval, Breo still has a way to go before it reaches pharmacy shelves.

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Review Date: 
April 18, 2013