Dupixent to treat pediatric patients with atopic dermatitis

Targeting age 6 to 11, the decision is to be made within the first quarter

Phase III trial confirms efficacy compared against TCS alone, improving severity and skin condition

The use of atopic dermatitis and asthma treatment Dupixent (dupilumab) could be expanding also in South Korea to be administered to children.

 

A pharmaceutical industry source reported Sanofi Genzyme has submitted an indication expansion application last year on Dupixent to be indicated for a ‘treatment in pediatric patients aged six through 11 with severe case of atopic dermatitis and underlying condition of various type 2 inflammations,’ and a ‘treatment in patients with type 2 inflammatory asthma and chronic rhinosinusitis with nasal polyps (CRSwNP).’ The approval decision would be made within the first quarter of the year.

 

A Phase III trial has reportedly confirmed the efficacy of Dupixent and topical corticosteroids (TCS) combination therapy in treating pediatric patients with atopic dermatitis.

 

The trial found the Dupixent combination group showed average 82 percent improvement from baseline in disease extent and severity, when administered every four weeks, compared to 49 percent improvement in placebo group.

 

Also for other indicators like skin itchiness and clearance, the combination therapy performed improved efficacy compared against TCS alone.

 

Even if the health authority approves of the additional indications, it is unclear how long it would take to expand the National Health Insurance (NHI) coverage.

 

Dupixent was authorized for sales in South Korea in March 2018, and it was listed for NHI reimbursement in January 2020 after submitting the application in February 2019.

 

Expanding the indication for pediatric patient would increase the usage significantly that the health authority and the applicant company would have to reach a difficult agreement for the coverage expansion.

 

Since January 2021, Dupixent was applied with a special case coverage for treating severe level of atopic dermatitis, bringing down the patient copayment rate from 60 percent to 10 percent.

 

Up until then patients paid about 12 million won for administering 27 doses per year at a tertiary hospital, but now with the special case coverage, the patients would only have to pay 2 million won annually.