ABBV AbbVie Inc

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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