FDA Approvals, Highlights, and Summaries: Dermatology

February 17, 2022

Adbry (tralokinumab)

Tralokinumab is an interleukin-13 (IL-13) inhibitor that blocks IL-13–induced responses (eg, release of proinflammatory cytokines, chemokines, IgE). It is indicated for moderate-to-severe atopic dermatitis in adults who are not adequately controlled with topical prescription therapies or in whom those therapies are not advisable.

Results from the phase 3 ECZTRA clinical trials showed tralokinumab to be superior to placebo at 16 weeks of treatment and tolerated for up to 52 weeks. Br J Dermatol. 2021 Mar;184(3):437-449

Other dermatology approvals

Otezla (apremilast) - Indicated for plaque psoriasis expanded to include any severity in adults who are candidates for phototherapy or systemic therapy.

Opzelura (ruxolitinib topical) - First JAK inhibitor topical dosage form. Indicated for topical short-term and noncontinuous long-term treatment of mild-to-moderate atopic dermatitis in nonimmunocompromised patients aged 12 years and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

Twyneo (tretinoin/benzoyl peroxide) - New combination approved for acne vulgaris in patients aged 9 years and older.

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