FDA Delays Review of Pfizer’s Abrocitinib and Xeljanz Filings

The FDA cited its ongoing review of Pfizer's post-marketing safety study, ORAL Surveillance, evaluating tofacitinib in rheumatoid arthritis patients, as a factor for the extensions.

The U.S. Food and Drug Administration (FDA) will not meet the Prescription Drug User Fee Act (PDUFA) goal dates for the New Drug Application for abrocitinib for the treatment of adults and adolescents with moderate to severe atopic dermatitis and the supplemental New Drug Application for Xeljanz/Xeljanz XR (tofacitinib) for the treatment of adults with active ankylosing spondylitis. 

The FDA cited its ongoing review of Pfizer's post-marketing safety study, ORAL Surveillance, evaluating tofacitinib in rheumatoid arthritis patients, as a factor for the extensions.

“We remain confident in the benefit-risk profiles of abrocitinib and Xeljanz both of which have been demonstrated in robust clinical trial programs,” says Michael Corbo, PhD, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development, in a news release. “For people who are suffering with moderate to severe atopic dermatitis or active ankylosing spondylitis, many have limited treatment options. We look forward to hearing from the FDA as we work to bring these important potential treatment options to the appropriate patients.”

The FDA had previously extended the PDUFA goal dates to early Q3 2021. ​