GSK submits filing to FDA for Trelegy Ellipta use in patients with asthma

GSK submits filing to FDA for Trelegy Ellipta use in patients with asthma

GlaxoSmithKline plc (GSK) and Innoviva, Inc. (INVA) have announced the filing of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (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.

Although asthma is understood to be an inflammatory condition, additional bronchodilation administered through multiple-inhalers, has been proven to have a beneficial effect on asthma symptoms and lung function. Single-inhaler triple therapy would introduce a new treatment paradigm for managing those adult patients who remain symptomatic on an ICS/LABA combination

Christopher Corsico, SVP Development, GSK said: “Around 30% of asthma patients adherent to ICS/LABA combination therapy still experience symptoms. This filing is an important step towards giving asthma patients an additional treatment option. If approved, this filing would make Trelegy Ellipta the first and only single inhaled triple therapy available for both asthma and COPD in the US.”

About asthma

Asthma is a chronic lung disease that inflames and narrows the airways. Asthma affects 358 million people worldwide. Despite medical advances, more than half of patients continue to experience poor control and significant symptoms impacting their daily lives. The causes of asthma are not completely understood but likely involve an interaction between a person’s genetic make-up and the environment. Key risk factors are inhaled substances that provoke allergic reactions or irritate the airways.

About the CAPTAIN Study

CAPTAIN (Clinical study of Asthma Patients receiving Triple therapy through A single INhaler) was a randomised, double-blind, active controlled, six-arm parallel group, global multicentre study evaluating FF/UMEC/VI (100/62.5/25 mcg, 200/62.5/25 mcg, 100/31.25/25 mcg, and 200/31.25/25 mcg) versus FF/VI (100/25 mcg and 200/25 mcg) given once-daily to patients whose asthma was inadequately controlled despite treatment with ICS/LABA (>250 mcg/day fluticasone propionate, or equivalent) maintenance asthma medication. In the study 2,436 patients were treated across 15 countries.