Roflumilast foam, 0.3%

Trade Name: Zoryve®
Company: Arcutis Biotherapeutics

Approval Dates/Comments: In December 2023, the US FDA approved roflumilast 0.3% topical foam for the treatment of seborrheic dermatitis (SD) in individuals ≥9 years of age. Roflumilast is a once-daily topical, selective phosphodiesterase type 4 inhibitor – it is the first drug approved for SD with a new mechanism of action in over 2 decades. This steroid-free foam is suitable for chronic use anywhere on the body, including hair-bearing body areas such as the scalp, face and trunk which can be more susceptible to SD. Regulatory approval was based on positive data from the pivotal phase 3 trial, STRATUM (NCT04973228). The primary efficacy endpoint was Investigator Global Assessment (IGA) success (IGA of clear or almost clear + a ≥2-grade improvement from baseline) at week 8. Almost 80% of patients treated with roflumilast achieved IGA success compared to 58% of vehicle-treated patients, with early disease improvement observed as early as week 2. About 50% of individuals reached complete clearance at week 8.

Birch triterpenes gel

Trade Name: Filsuvez®
Company: Chiesi Global Rare Diseases

Approval Dates/Comments: The FDA approved birch triterpenes (derived from birch bark) topical gel in December 2023 for the treatment of partial thickness wounds in patients aged ≥6 months with junctional epidermolysis bullosa (JEB) and dystrophic epidermolysis bullosa. This is the first approved treatment for wounds associated with JEB.

Rapamycin anhydrous gel, 3.9%

Trade Name: Qtorin™
Company: Palvella Therapeutics

Approval Dates/Comments: In November 2023, the FDA granted Breakthrough Therapy designation to Qtorin™ for the treatment of microcystic lymphatic malformations (microcystic LMs). This novel topical formulation is also currently under development for other serious, functionally debilitating skin diseases (e.g., pachyonychia congenita and the prevention of basal cell carcinomas [BCCs] in Gorlin Syndrome) that are driven by the overactivation of the mammalian target of rapamycin (mTOR) pathway.

Bimekizumab-bkzx for SC use

Trade Name: Bimzelx®
Company: UCB

Approval Dates/Comments: The FDA approved bimekizumab-bkzx in October 2023 for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Bimekizumab is the first and only approved psoriasis treatment designed to selectively inhibit two key cytokines driving inflammatory processes – interleukin 17A and interleukin 17F. Regulatory approval was supported by data from three Phase 3, multicenter, randomized, placebo and/or active comparatorcontrolled trials (BE READY, BE VIVID and BE SURE).

Secukinumab for SC use

Trade Name: Cosentyx®
Company: Novartis

Approval Dates/Comments: In October 2023, the FDA expanded the label of secukinumab to include treating moderate to severe hidradenitis suppurativa (HS) in adults. Secukinumab is the only FDA-approved fully human biologic that directly inhibits interleukin-17A, a major cytokine implicated in the inflammation of HS.

Ustekinumab-auub for SC/IV use

Trade Name: Wezlana™
Company: Amgen

Approval Dates/Comments: The FDA approved ustekinumab-auub (Wezlana™) in October 2023 as the first biosimilar to reference ustekinumab (Stelara®) for multiple inflammatory diseases including adults and children ≥6 years of age with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and patients ≥6 years of age with active psoriatic arthritis.

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