The FDA has approved a 1.5% topical cream formulation of the Janus kinase (JAK) inhibitor ruxolitinib (Opzelura – Incyte) for short-term, non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients ≥12 years old whose disease has not been adequately controlled with other topical prescription drugs. Ruxolitinib is the first JAK inhibitor to be approved for topical use and the first to be approved in the US for treatment of AD. An oral formulation of ruxolitinib (Jakafi) is approved for treatment of myelofibrosis, polycythemia...

The 1.5% cream formulation of the Janus kinase (JAK) inhibitor ruxolitinib (Opzelura – Incyte) has been approved by the FDA for topical treatment of nonsegmental vitiligo (NSV) in patients ≥12 years old. Opzelura is the first product to be approved by the FDA for this indication. It was previously approved for treatment of atopic dermatitis.

The FDA has approved a 0.15% cream formulation of the phosphodiesterase-4 (PDE4) inhibitor roflumilast (Zoryve – Arcutis) for topical treatment of mild to moderate atopic dermatitis (AD) in patients ≥6 years old. Roflumilast is the second PDE4 inhibitor to be approved in the US for treatment of AD; crisaborole (Eucrisa), which can be used in patients ≥3 months old, was the first. Roflumilast is available as Zoryve in a 0.3% cream for treatment of plaque psoriasis and a 0.3% foam for treatment of seborrheic dermatitis. It is also available in an oral formulation (Daliresp) for...

Tapinarof 1% cream (Vtama – Dermavant), an aryl hydrocarbon receptor (AhR) agonist, has been approved by the FDA for topical treatment of atopic dermatitis in patients ≥2 years old. Tapinarof is the first AhR agonist to be approved in the US for this indication. It was approved in 2022 for treatment of plaque psoriasis in adults.

Axatilimab-csfr (Niktimvo – Incyte), a colony stimulating factor-1 receptor-blocking antibody, has been approved by the FDA for intravenous treatment of chronic graft-versus-host disease (cGVHD) after failure of at least 2 lines of systemic therapy in patients weighing ≥40 kg. Corticosteroids are generally the first-line treatment for cGVHD. The oral kinase inhibitors ibrutinib (Imbruvica), ruxolitinib (Jakafi), and belumosudil (Rezurock) are also approved for treatment of cGVHD. Extracorporeal photopheresis has been used off-label.

The oral Janus kinase (JAK) inhibitor baricitinib (Olumiant – Lilly), which was previously approved by the FDA for treatment of moderately to severely active rheumatoid arthritis and treatment of COVID-19 in certain hospitalized adults, has now been approved for treatment of severe alopecia areata in adults. Baricitinib is the first systemic treatment to be approved in the US for this indication.

The FDA has approved ritlecitinib (Litfulo – Pfizer), an oral JAK and TEC kinase family inhibitor, for treatment of severe alopecia areata in patients ≥12 years old. Ritlecitinib is the second oral drug to be approved in the US for treatment of severe alopecia areata; baricitinib (Olumiant), a JAK inhibitor, is approved only for use in adults.

The subcutaneously injected interleukin-13 (IL-13) antagonist tralokinumab-ldrm (Adbry – Leo) and the oral Janus kinase (JAK) inhibitors abrocitinib (Cibinqo – Pfizer) and upadacitinib (Rinvoq – Abbvie) have been approved by the FDA for treatment of moderate to severe atopic dermatitis.