$恒瑞医药(SH600276)$ $艾伯维公司(ABBV)$ 

NORTH CHICAGO, Ill., June 25, 2021 /PRNewswire/ -- AbbVie (ABBV) today announced that the U.S. Food and Drug Administration (FDA) 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 post-marketing study, ORAL Surveillance, evaluating tofacitinib in patients with rheumatoid arthritis.

No formal regulatory action has been taken on the sNDAs for RINVOQ in psoriatic arthritis and ankylosing spondylitis.