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.


Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.