GlaxoSmithKline PLC and Innoviva Inc. are seeking expanded approval from the U.S. Food and Drug Administration for their triple-drug, once-daily inhaler Trelegy Ellipta to treat asthma in adult patients.
The supplemental new drug application for Trelegy Ellipta is based on results from phase 3 trial Captain that showed the therapy was better than GSK's Relvar/Breo Ellipta combination therapy in improving the lung function of people who have uncontrolled asthma.
Asthma patients have inflammation in the lungs that narrows the airways, leading to difficulty breathing, coughing and wheezing. The condition affects 358 million people worldwide, GSK noted in its Oct. 2 press release.
The inhaler, which combines the drugs fluticasone furoate, umeclidinium and vilanterol, is already approved by the FDA and the European Commission to treat patients with chronic obstructive pulmonary disease, which also inhibits the ability to breathe.
In May, GSK and Innoviva, which jointly developed Trelegy Ellipta, submitted an application with Japan's Ministry of Health, Labour and Welfare for approval of the medicine to treat COPD.
