GSK applies to widen indications for combined asthma drug
GlaxoSmithKline has submitted its Relvar Ellipta asthma drug to European regulators for approval as a extended once-daily treatment.
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Earlier in the year a huge study showed the drug combination helps sufferers better control the condition.
A combination of fluticasone furoate, an inhaled corticosteroid (ICS), and vilanterol, a long-acting β2-agonist (LABA), Relvar Ellipta is already approved for the regular treatment of patients aged 12 and over with asthma who are not adequately controlled on both ICS and 'as-needed' short-acting β2-agonist.
GSK is now also proposing the drug for those patients already adequately controlled on an ICS/LABA combination.
As part of its submission to the European Medicines Agency, GSK has shown positive data from a lung function study that concluded that patients who have well-controlled asthma are able to switch from twice-daily fluticasone propionate/salmeterol combination to a once-daily FF/VI, without compromising their lung function and with no new safety signals identified.
Drug delivery company Vectura receives a low single-digit percentage royalty on net sales of GSK’s Ellipta products, including Relvar.