The Food and Drug Administration (FDA) has granted Priority Review to abrocitinib (Pfizer), an oral Janus Kinase 1(JAK1) inhibitor, for the treatment of moderate to severe atopic dermatitis in patients aged 12 years and older.
The NDA submission is supported by data from the phase 3 JADE program consisting of the JADE MONO-1 and JADE MONO-2 trials, which compared abrocitinib 100mg and 200mg once daily to placebo in patients aged 12 years and older with moderate to severe atopic dermatitis. It also includes the JADE COMPARE trial, which compared abrocitinib 100mg and 200mg once daily to subcutaneous dupilumab 300mg every 2 weeks or placebo in patients aged 18 years and older on background topical therapy.
The co-primary end points across all 3 trials included the Investigator’s Global Assessment (IGA) score of clear (0) or almost clear (1) and a reduction from baseline of ≥2 points and 75% improvement from baseline on the Eczema Area and Severity Index (EASI) at week 12.
Results from JADE MONO-1 and JADE MONO-2 showed that both doses of abrocitinib achieved statistically significant improvements for the co-primary end points compared with placebo. Abrocitinib also met key secondary end points in both trials, including a statistically significant reduction in pruritus as early as week 2 with at least a 4-point improvement as measured by the pruritus numerical rating scale.
In JADE COMPARE, a statistically superior proportion of patients treated with both doses of abrocitinib met the co-primary end points compared with placebo at week 12, and maintained superiority at week 16. Dupilumab also demonstrated superiority to placebo at weeks 12 and 16. Findings from the study also showed that treatment with abrocitinib 200mg led to a statistically superior reduction in itch by week 2 compared with dupilumab.
“Abrocitinib has demonstrated strong efficacy at relieving the signs and symptoms of atopic dermatitis, including rapid reduction of itch, across multiple clinical trials,” said Jonathan Silverberg, MD, PhD, MPH, Department of Dermatology, The George Washington University School of Medicine and Health Sciences. “If abrocitinib is approved, it could make a meaningful difference in real-world clinical practice.”
Additional data from other studies in the JADE program will be presented and published in the coming months. The Company recently announced positive topline results from the phase 3 JADE TEEN trial of abrocitinib in patients aged 12 to less than 18 years with moderate to severe atopic dermatitis who were also on background topical therapy.
The FDA is expected to make a decision on the application in April 2021.
For more information visit pfizer.com.
FDA grants Priority Review and EMA accepts regulatory submission for Pfizer’s abrocitinib, an oral once-daily JAK1 inhibitor, for patients 12 and up with moderate to severe atopic dermatitis. [press release]. New York, NY: Pfizer, Inc; October 27, 2020.