GlaxoSmithKline and Theravance's inhaled lung drug Relvar has been approved in Europe to treat both asthma and chronic obstructive pulmonary disease.
Relvar is a combination of the inhaled corticosteroid fluticasone furoate and the long-acting beta2 agonist (LABA) vilanterol, delivered through the Ellipta inhaler. The drug was approved in the USA in May (but only for COPD) where it is called Breo.
As part of its assessment, the European Medicines Agency reviewed results of 10 clinical studies in 7,783 patients with COPD and 16 trials in 9,326 patients with asthma. The approval triggers a $15 million payment to GSK from Theravance, and the UK drugs major will bank a further $15 million when the product is launched.
Darrell Baker, head of GSK's global respiratory franchise, said the approval means that "healthcare professionals across Europe will have the option to prescribe an ICS/LABA that offers 24-hour efficacy from a once-daily dose, delivered in our new Ellipta inhaler".