British drugmaker GlaxoSmithKline (GSK) and Innoviva are seeking approval from the European Medicines Agency (EMA) for an additional indication of Trelegy Ellipta to treat adult patients with asthma.
The regulator has accepted the application for the use of once-daily and single-inhaler triple therapy, Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol or FF/UMEC/VI) to treat asthma in adults.
Trelegy Ellipta is a combination of three molecules in a single inhaler, which requires to take in a single inhalation, once a day.
The combination includes fluticasone furoate inhaled corticosteroid, umeclidinium long-acting muscarinic antagonist and vilanterol long-acting beta2-adrenergic agonist. The medicine is delivered via GSK’s Ellipta dry powder inhaler.
GSK’s application has been submitted based on data from the pivotal phase III (CAPTAIN) study, which assessed 2,436 adult asthma patients across 15 countries whose disease remained inadequately controlled despite treatment with a combination of an inhaled corticosteroid and a long-acting β2-agonist (ICS/LABA).
The CAPTAIN (clinical study of asthma patients receiving triple therapy through a single inhaler) was a randomised, double-blind, active-controlled, six-arm parallel-group and global multicentre study designed to asses FF/UMEC/VI against FF/VI given once-daily to patients whose asthma was inadequately controlled despite treatment with ICS/LABA maintenance asthma medication.
According to the company, the trial achieved its primary endpoint and showed a statistically significant improvement in lung function compared with the ICS/LABA Relvar/Breo Ellipta.
In November 2017, Trelegy Ellipta secured approval in the European Union to treat patients with chronic obstructive pulmonary disease (COPD) who are not adequately treated by an ICS/LABA combination, or a combination of LABA and long-acting muscarinic antagonist (LAMA).
Regulatory applications were also submitted for the Trelegy duplicate licences, Elebrato Ellipta and Temybric Ellipta. The submissions include Trelegy Ellipta to treat adult asthma patients in the US in December 2019, as well as in Japan in November 2019.