The U.S. Food and Drug Administration approved a new indication for GlaxoSmithKline plc and Innoviva Inc.’s Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’) for the treatment of asthma in patients aged 18 years and older adding to the product’s current license for use in patients with chronic obstructive pulmonary disease (COPD).
GlaxoSmithKline Plc said the company’s three-in-one drug Trelegy Ellipta met the main goal of a late-stage asthma study, signaling a possible boost to the British drugmaker’s lung medicines division.
GlaxoSmithKline plc and Innoviva Inc. announced the submission of a regulatory application to the Japanese Ministry of Health, Labour and Welfare for once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 100/62.5/25 mcg) under the proposed brand name of Trelegy Ellipta for the treatment of adults with chronic obstructive pulmonary disease. This is the first regulatory filing to be made in Japan for a triple COPD therapy in a single inhaler.
AstraZeneca said an inhaler for chronic obstructive pulmonary disease (COPD) delivered improved lung function in a late-stage trial that could challenge GlaxoSmithKline’s new three-in-one inhaler.
The U.S. Food and Drug Administration approved the first two-drug regimen to treat HIV, aimed at lessening the side effect burden of current treatments that combine three or four medicines.
The European Commission approved GlaxoSmithKline’s three-in-one inhaler Trelegy Ellipta for chronic lung disease.
GlaxoSmithKline filed its new three-in-one inhaled lung drug for U.S. approval, potentially putting it on track to reach the market ahead of rivals in 2017.