China has granted a new indication approval to Sanofi’s Dupixent (dupilumab) to treat younger patients with atopic dermatitis.
On Sep. 9, the NMPA approved Dupixent for patients aged 12 and above with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.
This is one of the two applications that Sanofi submitted for new indication approvals. The other one is for children aged 6 to 11 years with moderate-to-severe atopic dermatitis. Both filings were given priority review by the CDE.
Dupixent is the only therapy that targets the IL-4/IL-13 pathway, which is a key driver of the allergic or type 2 inflammation that underlies atopic dermatitis
In China, Dupixent is a foreign drug urgently needed in the clinic. It was approved in June 2020 to treat adult patients with moderate to severe atopic dermatitis, and it has been included in the national reimbursement drug list since last year.
As a common dermal condition, China is seeing more new cases of atopic dermatitis. A study in 2014 revealed that the prevalence of atopic dermatitis in students aged 6 to 20 years was only 0.7% in 2000, but had climbed up to 8.3% in children aged 3 to 6 years in Shanghai in 2012.