Positive CHMP recommendation for Relvar Ellipta

UK pharma giant GlaxoSmithKline (LSE: GSK) and US partner Theravance (Nasdaq: THRX) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for fluticasone furoate/vilanterol (FF/VI) under the proposed brand name Relvar Ellipta.

The CHMP recommended the drug for the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate: patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short acting beta2-agonists. It is also recommended for the symptomatic treatment of adults with chronic obstructive pulmonary disease (COPD) with a FEV1<70% predicted normal (post-bronchodilator) with an exacerbation history despite regular bronchodilator therapy

Relvar is a combination of the inhaled corticosteroid (ICS) fluticasone furoate “FF” and the long-acting beta2-agonist (LABA) vilanterol “VI”. Two strengths of FF/VI are proposed for asthma (92/22mcg and 184/22mcg) and one strength is proposed for COPD (92/22 mcg). All strengths will be administered once-daily using the Ellipta, a new dry powder inhaler (DPI).