New triple combo ‘Enerzair’ for asthma lands in 'Big 5'

Lands in SMC·SNUH·AMC etc.

Provides first-in-class inhaled ICS·LABA·LAMA combination option

‘Enerzair Breezhaler,’ a three-in-one triple combination therapy for asthma, can now be prescribed at general hospitals in Korea.

 

According to industry sources, Novartis Korea’s triple combination drug ‘Enerzair Breezhaler (mometasone·indacaterol·glycopyrronium)’ that contains ICS (inhaled corticosteroids) · LABA (beta2-agonist) · LAMA (long-acting muscarinic antagonist) has passed the review of drug committees (DC) of ‘Big-5’ general hospitals including Samsung Medical Center (SMC), Seoul National University Hospital (SNUH), Seoul Asan Medical Center, and Severance Hospital.

 

The company had sought rapid entry into the market after it was approved for insurance benefit in September last year.

 

Enerzair was approved for reimbursement as maintenance treatment of asthma in adult patients (aged 18 or older) who are not adequately controlled with a maintenance combination of LABA and a high-dose ICS who experienced one or more asthma exacerbations in the past 12 months.

 

As a first-in-class combination, Enerzair identified significant results in ▲lung function improvement ▲ exacerbation reduction ▲asthma control ▲quality of life improvement compared to existing two-drug therapy (ICS·LABA) and three-drug therapy (ICS·LABA·LAMA).

 

The drug’s lung function improvement effect was identified in the pivotal IRIDIUM study that compared the efficacy and safety of Enerzair with high-dose ICS·LABA.

 

(fluticasone·salmeterol, mometasone·indacaterol) in asthma patients.

 

In the study, high-dose Enerzair improved the primary endpoint of trough FEV1 (volume of air that can be forced out in the first second of expiration approximately 24 hours post-administration of study drug) by 76mL and 65mL compared to high-dose Atectura Breezhaler (ICS·LABA).

 

In the primary and secondary analysis, it showed a significant improvement in trough FEV1 (199mL) compared to high-dose fluticasone·salmeterol (FLU·SAL) that was administered twice-daily.

 

The FEV1 improvement that was identified at week 26 lasted until week 52.

 

Enerzair also significantly reduced asthma exacerbation rates by 36% (moderate or severe) and 42% (severe) versus high-dose FLU/SAL over 52 weeks.

 

In asthma control, high-dose Enerzair also showed a statistically significant improvement in the rate of patients whose scores improved over the clinically significant difference of 0.5 points at week 4, week 12, and week 52 in the Asthma Control Questionnaire score.

 

Meanwhile, Enerzair also demonstrated an improvement in quality of life even compared to a triple combination therapy that combines the ICS·LABA combo with LAMA.

 

In the ARGON study that compared the improvement in quality of life in patients with uncontrolled asthma of twice-daily FLU/SAL to once-daily tiotropium (TIO), both the medium-dose and high-dose Enerzair demonstrated non-inferiority in the change of Asthma Quality of Life Questionnaire (AQLQ) score from baseline.

 

Enerzair also met the primary endpoint, change in AQLQ from baseline at week 24, and demonstrated non-inferiority to its comparator.

 

In the secondary analyses, medium-dose and high-dose Enerzair improved asthma control (ACQ-7 score, -0.124) and lung function (trough FEV1, 96 mL] compared to high-dose FLU·SAL·TIO.