GlaxoSmithKline and Innoviva have applied in Europe to market Relvar Ellipta for extended use in patients with asthma who are already adequately controlled on inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA) therapy.
The treatment, which is comprised of the ICS fluticasone furoate (FF) and the LABA vilanterol (VI), is currently indicated in Europe 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 (SABA), and where use of a combination product (ICS/LABA) is appropriate.
The submission contains data from a non-inferiority lung function study which showed that patients who have well-controlled asthma are able to switch from twice-daily fluticasone propionate/salmeterol (Seretide Accuhaler) to once-daily FF/VI without compromising their lung function, noted GSK.
Relvar Ellipta, which is sold Breo Ellipta in the US, was approved for the treatment of asthma and COPD in Europe in 2013.
In May, evidence from the ‘real-world’ Salford Lung Study showed that patients initiated with Relvar Ellipta had twice the odds of achieving an improvement in asthma control than those continuing with their usual care, which included inhaled corticosteroids (ICS) administered as monotherapy or as ICS/LABA (long acting beta agonist) combinations.
‘Go’ for self-injected Benlysta
Meanwhile, the US Food and Drug Administration has approved a self-injected formulation of GSK’s lupus drug Benlysta (belimumab).
The decision means that, with some initial training, patients with Systemic Lupus Erythematosus (SLE) will be able to self-inject the therapy at home as opposed to having to receive therapy in a hospital or clinical setting
The approval marks the first subcutaneous self-injection treatment option for patients with SLE.
Benlysta was approved in the US in 2011 as an intravenous formulation.