Further setback for AbbVie's Rinvoq approval in USA

AbbVie (NYSE: ABBV) saw its share close down 1.5% at $112.98 on Friday, after it revealed that the US Food and Drug Administration has informed the company that the FDA will not meet the Prescription Drug User Fee Act (PDUFA) action dates for the supplemental New Drug Applications (sNDAs) for Rinvoq (upadacitinib) for the treatment of adults with active psoriatic arthritis and adults with active ankylosing spondylitis.

The FDA cited its ongoing review of Pfizer's (NYSE: PFE) post-marketing study, ORAL Surveillance, evaluating tofacitinib, trade names Xeljanz and Xeljanz XR, in patients with rheumatoid arthritis. Xeljanz and Rinvoq are both JAK inhibitors, a category that has come under increased FDA scrutiny due to an increased risk of blood clots and of death associated with the class.

No formal regulatory action has been taken on the sNDAs for Rinvoq in psoriatic arthritis and ankylosing spondylitis. In March this year the FDA extended the review period for Rinvoq by three months, in the treatment of adult patients with active psoriatic arthritis and atopic dermatitis.