AbbVie Says FDA Won't Meet Action Dates for Arthritis Drug Rinvoq

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.

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(END) Dow Jones Newswires

06-25-21 1014ET