Dupixent aims to meet unmet needs in COPD

A condition more fearful than lung cancer

Expanded indications in Korea on the 13th of last month... Korea's only targeted biological drug

Dupixent proven to reduce annual COPD exacerbation rate and improve lung function

Global sales of KRW 20 trillion last year, interest rises in whether the drug will lead the COPD market in addition to the atopic and asthma markets

Dupixent (dupilumab), which is leading the atopic dermatitis market, is seeking to enter the market as Korea's first chronic obstructive pulmonary disease (COPD) targeted biologic drug.

 

The company wants to open a new paradigm in the treatment of COPD, which has a high unmet need, based on Dupixent’s mechanism that targets interleukin (IL)-4 and IL-13.

 

Professor Chin Kook Rhee, Department of Respiratory Medicine at Seoul St.

 

Mary

Sanofi held a meeting on the 9th to highlight the expansion of Dupixent's COPD indication and announce its future plans.

 

COPD patients experience a decline in their quality of life due to dyspnea, fatigue, and acute exacerbations, and in severe cases, it can even lead to death.

 

However, even with the existing inhaler-based triple therapy, about 50% of patients still experience severe exacerbations, indicating an unmet need.

 

“COPD is a chronic condition that requires systemic corticosteroid drugs or antibiotic treatment due to repeated acute exacerbations, which significantly increases the health and economic burden,” said Professor Chin Kook Rhee of the Department of Respiratory Medicine at Seoul St.

 

Mary's Hospital, presented at the event.

 

”Once an acute exacerbation occurs, the risk of future acute exacerbations and cardiovascular disease increases.

 

In addition to the burden of treatment, the condition also brings a high social and economic burden, including nursing care costs, which are estimated to cost around KRW 1.4214 trillion per year.

 

Rhee added, “Many patients with COPD whose acute exacerbations are not sufficiently controlled, as well as COPD patients with elevated blood eosinophil levels due to type 2 inflammation are at high risk of experiencing an acute exacerbation or rehospitalization.” He added, “The mortality rate within 3.6 years after the first severe acute exacerbation is about 50%, so preventing acute exacerbations is one main goal of COPD treatment.” In this context, Dupixent's expanded indication for COPD is attracting attention as it is expected to benefit patients whose acute exacerbations are not sufficiently controlled.

 

Dupixent has been approved by the Ministry of Food and Drug Safety for additional maintenance treatment of adults with COPD whose blood eosinophil count is elevated and not adequately controlled with standard inhaler therapy.

 

This approval was granted following two Phase III clinical studies that showed a reduction in the annual exacerbation rate of COPD and significant improvements in lung function and patient quality of life.

 

According to the Phase III BOREAS and NOTUS studies, which became the basis for the indication expansions, the annual moderate-to-severe exacerbation rates at week 52 of Dupixent’s administration were 0.78 and 0.86, respectively, 30% and 34% lower than the placebo group’s 1.1 and 1.3, meeting the primary efficacy endpoint.

 

Pic of Dupixent

Improvement in lung function was observed as early as the second week of Dupixent treatment and was maintained until the 52nd week.

 

In the BOREAS and NOTUS clinical studies, the forced expiratory volume in one second (FEV1) before the use of bronchodilators was 160 mL and 139 mL at Week 12 of Dupixent administration, compared to 77 mL and 57 mL in the placebo group, and significant improvement was confirmed at Week 52, at 153 mL and 115 mL compared to the 70 mL and 54 mL.

 

in the placebo group.

 

“Dupixent selectively inhibits the signaling of IL-4 and IL-13, which can promote the activation and transport of type 2 inflammatory cells, including eosinophils,” said Rhee.

 

”Domestic and international guidelines also additionally recommend Dupixent.” He went on to say, “It is unusual for a Korean treatment guideline to recommend a drug before it is approved in Korea; this shows the high expectations and social demand for innovative new drugs in COPD and the dire unmet need.

 

It is also necessary to strengthen treatment access so that more COPD patients can benefit from the clinical benefits of Dupixent.” However, with separate treatments currently being provided for low-risk and high-risk groups, and a three-drug therapy being reimbursed for the high-risk group, Dupixent is likely to be positioned as the last treatment option.

 

“We welcome the introduction of a new treatment in an area where there was no choice when exacerbations continued after using the three-drug therapy, as Dupixent has proven to be beneficial even in this case,” said Rhee.

 

”Considering the situation of asthma, there is a possibility that Dupixent’s position may change in the long run and become an earlier line option to prevent exacerbations in COPD as well.” For Sanofi, Dupixent’s entry into the reimbursement system is likely to be a major task in order to expand its market influence in Korea.

 

A Sanofi official added, “Sanofi also has much vision and a sense of mission for the early diagnosis and early treatment of COPD and will strive to improve access to our drugs.”