The product is marketed under the brand name ‘Breo Ellipta’ and is indicated for asthma patients aged 12 years and older.
The sNDA is for approval of two dose regimens, 100/25mcg and 200/25mcg, administered once daily using the Ellipta dry powder inhaler.
The submission is based on data from the comprehensive clinical development program for FF/VI in asthma, which included 48 clinical pharmacology studies in 1,328 subjects and 23 clinical studies in 12,051 patients with asthma.
The filing is also based on data secured from the Phase III efficacy and safety study of FF/VI reported in December 2013.
In May 2013, FF/VI 100/25mcg was approved by the US FDA 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.
Image: GlaxoSmithKline headquaters in London, UK. Photo: courtesy of Maxwell Hamilton.