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

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  • 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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