Jan 28, 2020: The U.S.FDA has accepted Priority Review the supplemental Biologics License Application (sBLA) for Sanofi’s Dupixent® (dupilumab) as an add-on maintenance treatment for children aged 6 to 11 years with moderate-to-severe atopic dermatitis whose disease is not effectively controlled with topical prescription therapies or when those therapies are not advisable, target action date for the FDA decision is May 26, 2020.
Regardless of standard-of-care therapy, many young children suffering with moderate-to-severe atopic dermatitis continue to experience uncontrolled, persistent symptoms.
These children live with intense, persistent itching, skin lesions along with skin dryness, cracking, redness or darkness, crusting and oozing.
The sBLA is supported by the data that includes pivotal Phase 3 results on the efficiency and safety of Dupixent shared with topical corticosteroids (TCS) in children with severe atopic dermatitis.
Results of the trial shows, children treated with Dupixent and TCS experienced considerably improved measures of overall disease severity, skin clearing, itching and health-related quality of life, compared to TCS alone.
Adverse events more commonly observed with Dupixent included conjunctivitis, nasopharyngitis and injection site reactions, which is consistent with the previously documented safety profile of Dupixent in older populations.
In 2016, the FDA granted Breakthrough Therapy designation to review Dupixent for the treatment of severe atopic dermatitis in the childrens of 6 months to 11 years of age not well controlled on topical prescription medications.
MOA: Dupixent is a fully human monoclonal antibody that inhibits signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins.
Data from the Dupixent clinical trials have shown that IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a key role in atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP).
