Asthma drug 'Trelegy 200 Ellipta Inhaler' becomes available

at tertiary general hospitals in KOR

Demonstrated to improve Forced Expiratory Volume in 1 second (FEV1) changes through the Phase 3 CAPTAIN study

Expanded impact on regulatory diseases, such as COPD

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The asthma treatment 'Trelegy 200 Ellipta Inhaler' is now available for prescription at tertiary general hospitals.

 

According to industry sources, Trelegy 200 Ellipta Inhaler (fluticasone furoate·umeclidinium·vilanterol) has passed the drug committees (DC) of Korea's 'Big 5' tertiary general hospitals, including Samsung Medical Center, Seoul National University Hospital, Seoul St.

 

Mary's Hospital, Asan Medical Center in Seoul, and Sinchon Severance Hospital.

 

Trelegy 200 Ellipta Inhaler has been included in the insurance reimbursement list since March last year.

 

It can be prescribed to patients with 'severe asthma that is not properly managed with combination therapy containing intermediate-dose or high-dose inhaler corticosteroid or long-acting beta2-agonists.' The efficacy of Trelegy 200 Ellipta was demonstrated through the Phase 3 CAPTAIN study, which compared Trelegy Ellipta and dual combination therapy FF/VI (fluticasone furoate/ vilanterol) in 2,436 adult asthma patients aged 18 and above whose asthma cannot be controlled despite treatment with dual combination therapy ICS/LABA.

 

As the primary endpoint, each cohort’s Forced Expiratory Volume in 1 second (FEV1) changes at Week 24 were evaluated.

 

The results demonstrated statistical significance as Trelegy Ellipta-treated cohort showed 110 mL more FEV1 compared with FF/VI-treated cohort.

 

The safety profile of Trelegy Ellipta for asthma treatment in this study was consistent with the known profile of the individual drug components and their combinations.

 

The most common side effects were nasopharyngitis v(13-15%), headache (5-9%), and upper respiratory tract infection (3-6%).

 

Severe adverse responses occurred similar in all treatment groups.

 

Dr.

 

Jae-Won Jeong, a Professor at Inje University Ilsan Paik Hospital, explained, "Asthma is a chronic respiratory disease that requires lifetime management.

 

It's important for patients who experience worsening of asthma to receive proper treatments." Additionally, Dr.

 

Jeong said, "Major guidelines also recommend using triple combination therapy, with LAMA added to the ICS/LABA, as the optimal treatment option before the start of oral corticosteroid treatment for patients with severe asthma whose symptoms are not controlled with double therapy of ICS/LABA." Meanwhile, Trelegy 200 Ellipta is a once-daily single-inhaler triple combination therapy, approved in September 2022 as a maintenance therapy for Korean adult patients.

 

It obtained approval in 10 countries, including the United States, Japan, Canada, and Taiwan, and is being prescribed globally.

 

Additionally, Trelegy 100 Ellipta, approved for the first time in May 2018 in South Korea, is a once-daily single inhaler triple combination therapy for COPD and asthma.

 

It was approved in June 2021 for national health insurance reimbursement as the COPD maintenance therapy.

 

In March 2024, it expanded the scope of reimbursement for asthma indication.