Trelegy Ellipta filed with FDA for asthma in adults.- GSK + Innoviva

GlaxoSmithKline and Innoviva announced the filing of a supplemental New Drug Application (sNDA) to the FDA seeking an additional indication for the use of once-daily, single-inhaler triple therapy, Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol or FF/UMEC/VI), 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 (COPD). The submission is supported by the pivotal Phase III clinical study (CAPTAIN), conducted in 2,436 adult patients with uncontrolled asthma across 15 countries. Positive headline results were reported in May 2019.

Comment: FF/UMEC/VI is a combination of three molecules in a single inhaler that only needs to be taken in a single inhalation, once a day. It contains fluticasone furoate, an inhaled corticosteroid, umeclidinium, a long-acting muscarinic antagonist; and vilanterol, a long-acting beta2-adrenergic agonist, delivered in GSK�s Ellipta dry powder inhaler. FF/UMEC/VI was approved in the US under the brand name Trelegy Ellipta in September 2017 for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Trelegy Ellipta is not indicated for relief of acute bronchospasm or for the treatment of asthma.