Posted by Michael Wonder on 21 Jul 2021
Pfizer provides update on U.S. FDA review of abrocitinib and Xeljanz filings
21 July 2021 - Pfizer announced today that the U.S. FDA has notified the company that it will not meet the Prescription Drug User Fee Act 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 on-going review of Pfizer's post-marketing safety study, ORAL Surveillance, evaluating tofacitinib in rheumatoid arthritis patients, as a factor for the extensions.
