Pfizer announced key data and regulatory milestones for abrocitinib

In 2020, Pfizer took several important steps toward a potential option for people with moderate to severe atopic dermatitis by delivering on key data and regulatory milestones for abrocitinib, an investigational oral once-daily Janus kinase 1 (JAK1) inhibitor.

Through a robust Phase 3 clinical trial program, abrocitinib has demonstrated statistically superior improvements in skin clearance, disease extent and severity, as well as rapid improvements in itch versus placebo. Without relief, atopic dermatitis can have a debilitating impact on daily life for patients.

Five announcements around our clinical trial program recently showcased these data results, progressing toward possible regulatory decisions in 2021 (the outcome of which remains subject to regulatory review and labeling discussions):

1. March 18: Positive JADE COMPARE top-line results highlighted the effect of two doses of abrocitinib in patients on background topical therapy. The study also included an active control arm with dupilumab.
2. June 3: Complete results from JADE MONO-2, the second from a pair of replicate studies that evaluated two doses of abrocitinib monotherapy, reinforced the strong results from JADE MONO-1.
3. June 10: Positive results from JADE TEEN demonstrated the efficacy and safety profile of abrocitinib in patients 12 to less than 18 years old.
4. October 27: The U.S. Food and Drug Administration accepted for filing and granted priority review designation to abrocitinib, while the European Medicines Agency accepted the marketing authorization application.
5. November 11: Positive top-line results from JADE REGIMEN, which evaluated two doses of abrocitinib following response to initial open label induction treatment with abrocitinib 200mg.