News
An inhaled powder formulation of the corticosteroid fluticasone furoate and vilanterol, a long-acting beta-2 agonist, has been approved for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema.
It has also been approved to reduce chronic obstructive pulmonary disease (COPD) exacerbations in patients with a history of exacerbations, according to a statement issued May 10 by the Food and Drug Administration. In studies of 7,700 patients diagnosed with COPD, those treated with the inhaled corticosteroid/long-acting beta-2 agonist (ICS/LABA) combination "showed improved lung function and reduced exacerbations compared to placebo," the statement said.
The fixed-dose combination of 100 mcg of fluticasone furoate with 25 mcg of vilanterol is formulated in a dry powder. It is administered once a day in a new inhaler that provides 30 doses, according to GlaxoSmithKline, which developed the product with Theravance. The product will be marketed as Breo Ellipta.
As with other LABAs, the prescribing information for this product includes a boxed warning about the risk of asthma-related deaths, although it is not approved for treating asthma. Nasopharyngitis, oral candidiasis, headache, and upper respiratory tract infections were among the most common side effects reported by patients using the product, according to the FDA.
The approval was announced less than a month after the majority of the FDA’s Pulmonary-Allergy Drugs Advisory Committee voted to support approval of the product for long-term maintenance treatment of airflow obstruction and reducing COPD exacerbations. The panel nearly unanimously agreed that the treatment had "clinically meaningful" benefit as a long-term maintenance treatment for airflow obstruction They voted 8-5 that the data provided "substantial evidence" that reductions in exacerbations were clinically meaningful.
The two inhaled ICS/LABA treatments approved by the FDA for COPD are the combination of fluticasone propionate and salmeterol (Advair Diskus), also marketed by GSK, and the combination of budesonide and formoterol (Symbicort). Both are administered twice a day. Salmeterol and formoterol are both available as separate products to treat COPD. Vilanterol, which is the LABA component of Breo Ellipta, will not be available separately.
The label for Breo Ellipta can be found here.