According to a preliminary review, the U.S. Food and Drug Administration has found that GlaxoSmithKline's Breo Ellipta did not pose any new safety problems as a treatment option for asthma.
The review comes ahead of a meeting where FDA advisers will meet to discuss if the drug, a combination treatment involving a corticosteroid-long-acting beta-adrenoreceptor agonists (LABA) mix, will be approved for treating asthma. Specifically, Breo Ellipta contains the corticosteroid fluticasone furoate and the LABA vilanterol.
Corticosteroids work to improve breathing by smoothing inner surfaces in breathing pathways. LABA, on the other hand, has been associated with asthma-related deaths previously so the inclusion of the ingredient in a drug meant for treating asthma warranted a thorough safety review.
During the review, no asthma-related deaths were reported. There were asthma-related hospitalizations but data on the admissions were not uniformly observed in the 23 studies conducted by GlaxoSmithKline and used for the review. Data submitted by the company also showed that Breo Ellipta's safety profile was similar to other steroid-LABA combinations.
While the benefit of adding a LABA compound to the drug did not consistently manifest in the trials, there should be a discussion about the issue during the meeting. At the moment, three respiratory treatments from GlaxoSmithKline are available on the market and all carry warming for risks of asthma-related deaths.
Breo Ellipta has been previously approved by the FDA but the drug was assessed as treatment for chronic obstructive pulmonary disease. COPD is a breathing disability that worsens over time and most affects smokers.
FDA staff who reviewed Breo Ellipta also pointed out that the once-a-day dosage required by the drug can help patients adhere to treatments compared to taking medications that need administration twice daily. And when patients stick with treatment regimens more religiously, this promotes lower risks of their asthma worsening.
"As the first once-daily ICS/LABA, Breo Ellipta provides a safe and effective asthma treatment for patients aged 12 years and older. The efficacy and safety data in the Breo Asthma Clinical Development Program are robust and support regulatory approval," concluded [pdf] the review.
Breo Ellipta will be prescribed in two strengths (FF/VI 100/25 and FF/VI 200/25) depending on how severe an asthma case is at the start of treatment. Regimens will also be adjusted periodically to manage symptoms better. Aside from ensuring patient comfort, this will also allow doctors to optimally balance the benefits and risks of Breo Ellipta as asthma treatment.
