AbbVie: FDA Seeks More Data, Extends Rinvoq Review
18 March 2021 - 12:50AM
Dow Jones News
By Colin Kellaher
AbbVie Inc. Wednesday said the U.S. Food and Drug
Administration's review of its application for expanded use of its
JAK inhibitor Rinvoq has been extended after the agency sought more
information on the drug's benefit-risk profile.
The North Chicago, Ill., biopharmaceutical company, which is
seeking approval for Rinvoq for adults with active psoriatic
arthritis, said it responded to the FDA's request, and that the
agency extended its target action date by three months to late in
the second quarter while it reviews the submission.
AbbVie said the FDA made a similar request related to its
application for Rinvoq in atopic dermatitis. The company said it is
preparing its response and will submit its to the FDA shortly.
The company said it remains confident in the applications, and
that it is committed to working with the FDA to bring Rinvoq to
patients living with psoriatic arthritis and other immune-mediated
diseases.
The FDA in 2019 approved Rinvoq for adults with moderately to
severely active rheumatoid arthritis.
Shares of AbbVie, which closed Tuesday at $110.84, fell 7% in
premarket trading Wednesday.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
March 17, 2021 09:35 ET (13:35 GMT)
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