FDA New Drug and Biologic Approvals -- 2017 Year-in-Review

Mary L Windle, PharmD

Disclosures

January 11, 2018

In This Article

Dupixent (dupilumab)

Indication:

Adults with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies.

Mechanism:

Monoclonal antibody that inhibits interleukin-4 (IL-4) and IL-13 signaling.

Dosage:

600 mg (ie, two 300-mg injections) SC once, and then 300 mg SC every other week.

Approval:

Approval was based on clinical trials investigating dupilumab as monotherapy (SOLO 1 and SOLO 2) and in concomitant administration with topical corticosteroids (CHRONOS). Results from the SOLO 1 (n=671) and SOLO 2 (n=708) trials showed 36-38% of patients who received dupilumab had scores of 0 or 1 (clear or almost clear) on the Investigator's Global Assessment scale compared with placebo (8-10%) (P<0.001). Additionally, improvement from baseline to week 16 of at least 75% on the Eczema Area and Severity Index was reported in significantly more patients who received each regimen of dupilumab than in patients who received placebo (P<0.001).

Reference:

Simpson EL, et al. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis. N Engl J Med. 2016 Dec 15;375(24):2335-48.

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