FDA Will Not Meet Goal Dates For Pfizer's Xeljanz, Abrocitinib Applications

The FDA will not meet PDUFA goal dates for Pfizer Inc's PFE marketing application for abrocitinib for severe atopic dermatitis and the supplemental application for Xeljanz/Xeljanz XR (tofacitinib) for 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.
As communicated in April, the FDA had previously extended the PDUFA goal dates to early Q3 2021.
Abrocitinib is an oral small molecule that selectively inhibits Janus kinase (JAK).
Xeljanz (tofacitinib) is approved in the U.S. in four indications.
Price Action: PFE shares are up 0.05% at $41.04 during the premarket session on the last check Thursday.
Related content: Benzinga's Full FDA Calendar.