FDA Will Not Meet Goal Dates For Pfizer's Xeljanz, Abrocitinib Applications
- The FDA will not meet PDUFA goal dates for Pfizer Inc's (NYSE: 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.
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Posted-In: atopic dermatitis Briefs spondylitisBiotech News Health Care FDA General
