FDA panels approve Breo Ellipta for asthma in adults, not kids

FDA committees recently voted to approve GlaxoSmithKline and Theravance’sBreo Ellipta (fluticasone furoate/vilanterol) as an asthma treatment for adults 19 years and older, but not for patients aged 12 to 17 years.

The Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee of the U.S. reviewed the New Drug Application (sNDA) for Breo Ellipta (fluticasone furoate/vilanterol [FF/VI]) as a once-daily inhaled treatment for asthma.

Based on the opinions of the FDA Advisory Committee and the data presented, FDA will make its final decision on approval, which is expected April 30.

The committees also recommended that a large long-acting beta2-adrenergic agonists (LABA) safety trial with FF/VI should be required in adults and in 12 to 17 year olds, similar to the ongoing LABA safety trials being conducted as an FDA Post-Marketing Requirement by each of the manufacturers of LABA containing asthma treatments.

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LABAs, such as vilanterol, one of the active ingredients in Breo Ellipta, increase the risk of asthma-related death. A placebo-controlled trial with another LABA (salmeterol) showed an increase in asthma-related deaths in subjects receiving salmeterol, according to GlaxoSmithKline. This finding with salmeterol is considered a class effect of all LABAs, including vilanterol. In the United States, the safety and efficacy of Breo Ellipta in patients with asthma have not been established and therefore Breo Ellipta is not indicated for the treatment of asthma.

As with other inhaled medicines, Breo Ellipta can produce paradoxical bronchospasm which may be life-threatening. Vilanterol, the LABA in Breo Ellipta, can produce clinically significant cardiovascular effects in some patients as measured by increases in pulse rate, systolic or diastolic blood pressure, and also cardiac arrhythmias, according to GlaxoSmithKline. Decreases in bone mineral density have been observed with long-term administration of products containing inhaled corticosteroids, as have glaucoma, increased intraocular pressure, and cataracts.

The most common adverse reactions ( ≥3% and more common than in placebo) reported in two 6-month clinical trials with Breo Ellipta (and placebo) were nasopharyngitis, 9% (8%); upper respiratory tract infection, 7% (3%); headache, 7% (5%); and oral candidiasis, 5% (2%). In addition to the events reported in the 6-month studies, adverse reactions occurring in ≥ 3% of the subjects treated with Breo Ellipta in 2, 1-year studies included COPD, back pain, pneumonia, bronchitis, sinusitis, cough, oropharyngeal pain, arthralgia, hypertension, influenza, pharyngitis, diarrhea, peripheral edema, and pyrexia.

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