Sanofi said Wednesday that Dupixent (ingredient: dupilumab) has won regulatory approval for children aged 6-11 with atopic dermatitis and adults with chronic rhinosinusitis accompanying nasal polyps.

Dupixent, the only biological drug prescribed for atopic dermatitis, has expanded indications to treat atopic dermatitis patients of all ages in Korea. It is also the first therapy to acquire indication for treating chronic rhinosinusitis with nasal polyp.

Children with atopic dermatitis had limited treatments, but the expanded indication provides a new therapy with proven efficacy and safety profile, Sanofi said.

Dupixent is the only biologic drug that has obtained indications for atopic dermatitis in children above 6. The European Academy of Dermatology and Venereology also recommends using Dupixent for atopic dermatitis in children and adolescents.

The drug demonstrated its efficacy in phase 3 clinical study, known as the LIBERTY AD PEDS involving 367 children aged 6-11. The drug quickly improved skin lesions, itching, and quality of life of children with atopic dermatitis. At the 16th week of the study, patients who received Dupixent with topical corticosteroid once in two or four weeks depending on their weight scored 75 percent improvement in the eczema area and severity index, proving safety and efficacy.

Regulators also approved using Dupixent for adult chronic rhinosinusitis patients with nasal polyps based on phase 3 studies -- SINUS-24 and SINUS 52 -- on 724 participants.

In the SINUS-24 study, patients showed 51 percent improvement in their nasal congestion and obstruction compared to 16 percent with placebo at the 24th week. Also, at week 52, the drug improved the severity of nasal congestion and obstruction by 54 percent compared to baseline, demonstrating its lasting treatment effect.

The medicine also significantly enhanced lung function in chronic rhinosinusitis patients with nasal polyps and co-morbid asthma.

“The expanded indication will provide a more fundamental treatment option for children with atopic dermatitis and those with chronic rhinosinusitis accompanying nasal polyps,” said Park Hee-kyung, CEO of Sanofi Genzyme, a specialty care global business unit of Sanofi in Korea. “We hope Dupixent to provide hope for patients and medical staffs who suffered from recurrence and reoperation.”