Oral JAK Abrocitinib to Adolescents with Atopic Dermatitis Is Expanded by FDA

On February 10, FDA expanded the indication for Pfizer’s oral Janus kinase (JAK) inhibitor for atopic dermatitis (AD), abrocitinib (Cibinqo), to include adolescents aged 12 through 17 years. 
Previously, only adult patients over 18 years could take the once-daily abrocitinib.  

Now, it joins upadacitinib (Rinvoq) as the only oral JAK inhibitor approved for use by adolescents aged 12 through 17 with refractory, moderate to severe AD. The doctor may prescribe this medication when other systemic drugs, including biologics, do not adequately control the disease of adolescents or if these other drugs are not recommended.  

The new prescribing information reflects the data from JADE TEEN, a phase 3, randomized, placebo-controlled trial. The study evaluated both the 100-mg and 200-mg doses of abrocitinib in comparison with a placebo in 285 adolescents aged 12 to 18 who had moderate to severe AD and were also receiving background therapy with topical medications. The study confirmed the feasibility and effectiveness in adolescents.  

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