Biotechnology company Sanofi (EURONEXT:SAN) (NASDAQ:SNY) reported on Monday the receipt of approval for Dupixent to help clear the skin and reduce itching in adolescent patients with moderate-to-severe atopic dermatitis under the US Food and Drug Administration (FDA) priority review and breakthrough therapy designation.
Additionally, Dupixent can be used with or without topical corticosteroids and is available in 200 mg and 300 mg doses, each as a pre-filled syringe, said the company.
The company added that the US FDA has approved Dupixent (dupilumab) for adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.
According to the company, dupixent is a targeted biologic therapy that inhibits signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two key proteins that may play a central role in type 2 inflammation that underlies atopic dermatitis and several other allergic diseases.
In conjunction, dupixent has been studied in more than 7,000 patients 12 years and older in over 30 clinical trials. Its safety profile in the adolescent trial was similar to the safety profile from trials in adults with atopic dermatitis and consistent through 52 weeks.
Atopic dermatitis, a form of eczema, is a chronic inflammatory disease with symptoms often appearing as a rash on the skin. Moderate-to-severe atopic dermatitis is characterised by rashes that can cover much of the body and can include intense, persistent itching, skin lesions and skin dryness, cracking, redness, crusting and oozing.
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