AbbVie (NYSE: 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.
"RINVOQ has demonstrated strong efficacy data, a safety profile that is well characterized from large long-term studies and a favorable benefit-risk profile," said Michael Severino, M.D., vice chairman and president, AbbVie. "We remain committed to working with the FDA to bring RINVOQ to patients living with psoriatic arthritis, ankylosing spondylitis and other immune-mediated diseases."
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.