FDA Delays Approval for Abrocitinib for Atopic Dermatitis

The FDA did not meet the PDUFA goal date for abrocitinib (PF-04965842; Pfizer), a potential treatment of moderate to severe atopic dermatitis in adults and adolescents.

The FDA will not meet the Prescription Drug User Fee Act (PDUFA) goal date of July 27 for abrocitinib (PF-04965842; Pfizer), a potential treatment of moderate to severe atopic dermatitis in adults and adolescents, according to an announcement from Pfizer.1

The FDA cited its ongoing review of Pfizer's ORAL Surveillance, a post-marketing safety study evaluating tofacitinib in rheumatoid arthritis patients. Originally set for April 2021, the FDA extended the review of abrocitinib’s New Drug Application (NDA) by 3 months to July.

Abrocitinib is a once-daily, oral Janus kinase 1 (JAK1) inhibitor for moderate to severe AD in patients 12 years and older. Inhibition of JAK1 is said to influence interleukin (IL)-4, IL-13, IL-22, IL-31 and interferon gamma–all of which are thought to be involved in the pathophysiology of AD.

Fillings for the drug are supported by positive results from studies in the abrocitinib JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program. The submitted studies include JADE MONO-1 and JADE MONO-2, which investigated abrocitinib as a monotherapy; and JADE COMPARE, which evaluated the drug compared to placebo in patients on background topical therapy while also comparing the drug to an active control arm consisting of dupilumab (Dupixent; Sanofi and Regeneron) vs placebo.

In JADE COMPARE, abrocitinib met all co-primary endpoints and both doses (100 mg and 200 mg) of abrocitinib demonstrated superiority over placebo at week 16 and was sustained until week 16.

Meanwhile, results from JADE MONO-1 also met all co-primary and secondary endpoints, including a proportion of patients who achieved an IGA score of 0 or 1 and at least a 2-point improvement, and a proportion of patients who achieved 75% or more change from baseline in their Eczema Area and Severity Index (EASI) score. Secondary endpoints included a proportion of patients achieving a 4-point or more reduction in itch severity measured with the pruritus numerical rating scale (NRS) and the magnitude of decrease in the Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD).

Additionally, results from JADE MONO-2 met all primary and secondary endpoints while demonstrating statistical superiority to placebo. Investigators reported both doses (100 mg and 200 mg) of abrocitinib subjects achieved EASI-75, EASI-90, PP-NRS and IGA responses in a greater proportion vs placebo.

Reference:

  1. Pfizer provides update on u. S. Fda review of abrocitinib and xeljanz® filings | pfpfizeruscom. Accessed July 22, 2021. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-provides-update-us-fda-review-abrocitinib-and