GlaxoSmithKline plc and Theravance, announced the submission of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (US FDA) for a fixed dose combination of the inhaled corticosteroid, fluticasone furoate and the long-acting beta2 agonist, vilanterol (FF/VI) as a once-daily treatment for asthma in patients aged 12 years and older, with the brand name of Breo Ellipta.
The sNDA is seeking approval for two dose regimens, 100/25mcg and 200/25mcg, administered once daily using the Ellipta dry powder inhaler.
Today’s filing is based upon 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.
Asthma is a chronic lung disease that inflames and narrows the airways, causing recurring periods of wheezing, chest tightness, shortness of breath and coughing which often occurs at night or early in the morning.
Despite medical advances, more than half of patients continue to experience poor control and significant symptoms.
The causes of asthma are not completely understood but likely involve an interaction between a person’s genetic make-up and the environment. Key risk factors are inhaled substances that provoke allergic reactions or irritate the airways. These include allergens such as dust mites and pets.
FF/VI 100/25mcg was approved by the US Food and Drug Administration under the brand name Breo Ellipta in May 2013 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.
RELVAR, BREO, and ELLIPTA are trade marks of the GlaxoSmithKline group of companies.