GSK's Relvar Ellipta Recommended for Marketing Authorisation in Europe
GSK and Theravance announced a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use recommending marketing authorisation for Relvar Ellipta.
London – GlaxoSmithKline (GSK) and Theravance announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for fluticasone furoate/vilanterol (FF/VI), proposed brand name RELVAR™ ELLIPTA™.
The medication is recommended for the regular treatment of asthma in adults and adolescents aged 12 years and older, where a combination inhaler (long-acting beta2-agonist and inhaled corticosteroid) is appropriate. It is also recommended for the symptomatic treatment of adults with Chronic Obstructive Pulmonary Disease (COPD) who have experienced exacerbations despite regular bronchodilator therapy.
RELVAR ELLIPTA combines the inhaled corticosteroid fluticasone furoate with the long-acting beta2-agonist vilanterol. Two strengths are proposed for asthma (92/22 mcg and 184/22 mcg) and one strength for COPD (92/22 mcg). All strengths are to be administered once daily using the new Ellipta dry powder inhaler.
The CHMP's positive opinion is a key step before a final marketing authorisation decision by the European Commission, expected in the fourth quarter of 2013. The assessment was based on 11 clinical studies in COPD patients and 16 studies in asthma patients, involving over 17,000 participants in total. The drug has previously received approval in the US and Canada for COPD treatment under the brand name BREO™ ELLIPTA™.