Dupixent(dupilumab)

Dupixent (dupilumab) is indicated for the treatment of patients aged 6 years and older with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. It is also approved as an add-on maintenance treatment in patients with moderate to severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid dependent asthma. Additionally, Dupixent is indicated for the treatment of adult and pediatric patients ages 12 years and older, weighing at least 40 kg, with eosinophilic esophagitis.

Key efficacy findings include a 76.1% EASI-75 improvement and 39.1% of patients achieving an IGA score of 0 or 1 with a reduction of >= 2 points. For asthma, a FEV1 LS mean change from baseline of 0.32 L and a 21% FEV1 percent change from baseline were observed. Systemic exposure geometric mean ratios (AI/PFS) had a 90% CI of 80% to 125%.

Notable safety findings include a 3.3% withdrawal due to adverse events (Combined) and 7.8% of patients withdrawn from treatment (Combined). The antidrug antibody (ADA) response was observed in 2.33% and 14.3% of patients. The drug received approval on June 18, 2020, and May 20, 2022, for different indications. The atopic dermatitis indication extension date was 05/26/2020.