AbbVie Says FDA Won't Meet Action Dates for Arthritis Drug Rinvoq
June 25 2021 - 10:25AM
Dow Jones News
By Sarah Coffey
AbbVie Inc. on Friday said the U.S. Food and Drug Administration
won't meet the Prescription Drug User Fee Act action dates for the
supplemental new drug applications for its arthritis drug
Rinvoq.
The FDA cited its ongoing review of Pfizer Inc.'s post-marketing
study evaluating tofacitinib in patients with rheumatoid arthritis,
AbbVie said.
No formal regulatory action has been taken on the sNDAs for
Rinvoq in psoriatic arthritis and ankylosing spondylitis, the
company said.
"We remain committed to working with the FDA to bring Rinvoq to
patients living with psoriatic arthritis, ankylosing spondylitis
and other immune-mediated diseases," said Michael Severino, vice
chairman and president at AbbVie.
Write to Sarah Coffey at sarah.coffey@wsj.com
(END) Dow Jones Newswires
June 25, 2021 10:14 ET (14:14 GMT)
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