GlaxoSmithKline PLC and Innoviva Inc. said the European Commission approved Relvar Ellipta to treat patients whose asthma is already adequately controlled by a similar type of medicine.
Relvar Ellipta consists of a combination of fluticasone furoate, an inhaled corticosteroid, or ICS, and vilanterol, a long-acting ß2-agonist, or LABA.
The inhaler is already approved in Europe for asthma patients aged 12 years and older who can be treated with the ICS/LABA combination.
"This label update gives doctors the option of switching appropriate patients from their current ICS/LABA to once-daily Relvar Ellipta," said Jonathan Sweeting, senior vice president and head of global respiratory franchise at GlaxoSmithKline.
The approval was supported by a non-inferiority study showing that asthma patients with adequately controlled asthma were able to safely switch to Relvar Ellipta from the twice-daily Seretide Accuhaler, also owned by GlaxoSmithKline.
