FDA expanded the indication for Pfizer's oral JAK inhibitor for atopicdermatitis, abrocitinib, to include adolescents aged 12 through 17 years. DermTwitter
February 10, 2023
The indication has been expanded for teens whose disease is not adequately controlled with other systemic drugs, including biologics, or those for whom use of those drugs is not advised.was updated to reflect data from JADE TEEN, a phase 3, randomized, placebo-controlled trial that supported the indication for adolescents.
Data included in the prescribing information now encompass five randomized, placebo-controlled clinical trials and a long-term extension study with more than 1600 patients treated with abrocitinib, according to the statement from Pfizer.
AD, one of the most common inflammatory skin diseases, affects approximately 5% to 10% of adults in the USin the US. About 1 in 3 adults and 1 in 3 children and adolescents aged 17 and younger with AD have moderate to severe disease.
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