Sanofi 'Dupixent' adds COPD indication

following atopic dermatitis·asthma

Won European approval at the end of last year and FDA approval early this year…approved to expand indication on the 13th

The first and only biologic medication for chronic obstructive pulmonary disease (COPD) to be approved in South Korea

Closer to generating global sales of KRW 20 trillion last year…Dupixent's sales are expected to skyrocket

'Dupixent,' dominating the market for atopic dermatitis·asthma drugs, has expanded treatment areas to chronic obstructive pulmonary disease (COPD), thus gaining attention.

 

Since Dupixent was approved for expanded reimbursement last year, the latest news on COPD indication will likely improve its prescription competitiveness.

 

Product photo of Dupixent

According to pharmaceutical industry sources, Dupixent (dupilumab) was approved by the Ministry of Food and Drug Safety (MFDS) on the 13th for expanded indication to include add-on maintenance therapy to treat adult COPD who have an elevated blood eosinophil count and are not adequately controlled by standard inhaled therapy.

 

Patients with COPD experience decreased quality of life due to trouble breathing, fatigue, and acute exacerbation, and the disease may lead to death if worsened.

 

However, even if triple combination therapy, consisting of conventional inhalation therapy, is used, about 50% of patients still experience severe worsening.

 

Therefore, patients have unmet needs for treatment.

 

Dupixent works by targeting signaling pathway of interleukin (IL)-4 and IL-13, which are primary cause of type 2 inflammation.

 

Dupixent became the first and only domestically approved targeted biologic medication for COPD.

 

The drug is expected to provide new clinical benefits to patients with COPD who do not respond to conventional treatments.

 

The current approval was based on two Phase 3 clinical studies, demonstrating a reduction in COPD annual rate of exacerbations and a significant improvement in lung function and patient quality of life.

 

According to the Phase3 BOREAS and NOTUS, serving basis of expanded indication, at 52 weeks of Dupixent administration, the annual rates of moderate or severe exacerbations were 0.78 and 0.86, respectively, which were 30% and 34% lower than the 1.1 and 1.3 of the placebo group.

 

The results met the primary endpoints for efficacy.

 

Additionally, improvement in lung function started to show from week 2 of administration and maintained up to week 52.

 

In the BOREAS and NOTUS clinical studies, the prebronchodilator FEV1 at week 12 increased from 77 mL and 57 mL of the placebo group to 160 mL and 139 mL with Dupixent, and FEV1 at week 52 increased from 70 mL and 54 mL to 153 mL and 115 mL, demonstrating significant improvement in effects.

 

The St George's Respiratory Questionnaire (SGRQ) score of 4 or above had improved from 43% and 47% of the placebo group to 51.5% and 51.4% of the Duxient group.

 

Both clinical studies showed a consistent safety profile of Dupixent, similar to previous studies.

 

Kay Bae, Sanofi-Aventis Korea Country Lead, said, "COPD has a high disease burden due to acute exacerbations and lung function deterioration.

 

However, it has high unmet needs because there are patients whose symptoms are not regulated with conventional treatments," adding, "The diagnosis rate is low.

 

Thus, many patients who require treatment are not properly being treated." "As Dupixent is the first-and-only approved targeted biologic medication, it is expected to provide a new treatment paradigm for COPD.

 

We hope that current approval will allow more patients with COPD to receive treatments, thereby improving their symptoms and quality of life," Bae said.

 

According to Sanofi's reporting on performance, Dupixent's global sales for last year amounted to EUR 13.11 billion (approximately KRW 19.7 trillion), which was an increase of 23.1% from EUR 10.715 billion in 2023.

 

The fourth quarter sales amounted to EUR 3.5 billion (approximately KRW 5.3 trillion), showing an increasing trend.

 

In South Korea, Dupixent's sales surpassed KRW 100 billion, with KRW 105.2 billion in 2022, based on IQVIA.

 

After that, it recorded KRW 143.2 billion in 2023, showing an increasing trend.

 

Additionally, the impact of Dupixent is anticipated to grow due to the approval of expanded indication to include severe atopic dermatitis and drug switching between JAK inhibitors.

 

Dupixient is effective in diseases that occur due to type 2 inflammation, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, and eosinophilic esophagitis.

 

It is expected to add indications in diseases with similar mechanisms.

 

Sanofi is conducting Phase 3 clinical trials on Dupixent, aiming to secure indications in chronic spontaneous urticaria (CSU), chronic pruritus of unknown origin (CPUO), and bullous pemphigoid (BP).