Posted by Michael Wonder on 02 Oct 2019
GSK submits filing to FDA for Trelegy Ellipta use in patients with asthma
2 October 2019 - GSK and Innoviva today announced the filing of a supplemental new drug application to the US FDA seeking an additional indication for the use of once-daily, single-inhaler triple therapy, Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol), for the treatment of asthma in adults.
Trelegy Ellipta was approved in the US in September 2017 for the treatment of patients with Chronic Obstructive Pulmonary Disease.
The submission is supported by the pivotal Phase III clinical study (CAPTAIN), conducted in 2,436 adult patients with uncontrolled asthma across 15 countries.
