GlaxoSmithKline (GSK) and Theravance have submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) for a fixed dose combination of fluticasone furoate and vilanterol (FF/VI) as a once-daily treatment for asthma in patients aged 12 years and older.
Fluticasone furoate is an inhaled corticosteroid and vilanterol is long-acting beta2 agonist.
GSK and Theravance have filed the sNDA under the brand name Breo Ellipta and are seeking approval for two dose regimens, 100/25 micrograms and 200/25 micrograms, administered once-daily using the Ellipta dry powder inhaler.
The submission is supported by data generated from the comprehensive clinical development programme for FF/VI in asthma.
The clinical development programme comprised 48 clinical pharmacology studies in 1,328 subjects and 23 clinical studies in 12,051 patients with asthma, including the Phase III efficacy and safety study of FF/VI reported in December 2013.
In May 2013, the FDA approved FF/VI 100/25 micrograms under the brand name Breo Ellipta as a prescription medication for the long-term, once-daily, maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Breo Ellipta is not indicated for the relief of acute bronchospasm or the treatment of asthma in the US.
The most common adverse reactions reported in two six-month clinical trials with Breo Ellipta (and placebo) were nasopharyngitis, upper respiratory tract infection, headache, and oral candidiasis.
The adverse reactions reported in two one-year clinical trials with Breo Ellipta included COPD, back pain, pneumonia, bronchitis, sinusitis, cough, oropharyngeal pain, arthralgia, hypertension, influenza, pharyngitis, diarrhea, peripheral edema, and pyrexia.
Image: GlaxoSmithKline at Center City in Philadelphia, US. Photo: courtesy of Beyond My Ken.