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FDA Staff Find No New Safety Problems With Breo Ellipta (Fluticasone Furoate/Vilanterol) in Asthma Patients

Upcoming advisory committee meeting will mull drug’s approval

Breo Ellipta (fluticasone furoate/vilanterol, GlaxoSmithKline), a respiratory treatment for chronic breathing problems, did not show any new safety problems while being tested to treat asthma, a preliminary review by FDA staff has found.

The review comes 2 days ahead of a joint meeting of the FDA’s Pulmonary–Allergy Drugs Advisory Committee (PADAC) and Drug Safety and Risk Management Advisory Committee (DSaRM) to discuss the safety of Breo Ellipta and to recommend whether it should be approved for use in patients with asthma.

Breo Ellipta is a combination inhalation product consisting of fluticasone furoate, an inhaled corticosteroid, and vilanterol, a long-acting beta-agonist (LABA). The drug was approved in May 2013 for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, and to reduce exacerbations of COPD in patients with a history of exacerbations.

Breo Ellipta is available as a dry-powder inhaler, and the approved dose is 100 mcg fluticasone furoate and 25 mcg vilanterol once daily. The new supplemental NDA proposes two doses of Breo Ellipta –– 100/25 (fluticasone furoate 100 mcg and vilanterol 25 mcg inhalation powder) and 200/25 (fluticasone furoate 200 mcg and vilanterol 25 mcg inhalation powder) –– with a once-daily dosing regimen for asthma patients aged 12 years and older.

Vilanterol belongs to a class of compounds (LABAs) that have historically been linked to asthma-related deaths. In their briefing document, however, the FDA staff said that no such deaths were observed in the Breo Ellipta studies that they had reviewed.

The staff also said that the safety profile of Breo Ellipta in the treatment of asthma was similar to that of other combinations of steroids and LABA compounds.

In their upcoming meeting, the FDA advisory committees will discuss the fact that the benefit of adding a LABA compound to a steroid was not demonstrated consistently in the Breo Ellipta trials. GlaxoSmithKline already has three respiratory treatments containing a LABA compound on the market, and each of these products carries a boxed warning that the drug could increase the risk of asthma-related deaths.

This possible adverse effect was verified in a study that tested another of Glaxo’s LABA compounds, salmeterol (Serevent Diskus), against placebo. Salmeterol, on the market since 1994, is approved for the treatment of asthma in combination with an inhaled steroid.

Sources: Reuters; March 17, 2015; and FDA Briefing Document; March 19, 2015.

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