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AbbVie Slips on FDA Delay in Arthritis-Drug Action Dates

AbbVie says the FDA informed the company that it will not meet two action dates for its drug applications.
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AbbVie  (ABBV) - Get Free Report slipped on Friday after the drugmaker said it had been notified by the Food and Drug Administration that the agency will not meet the action dates for two supplemental new drug applications for its psoriatic arthritis treatment.

Shares of AbbVie were down 1.5% to $113.05 in trading Friday.

AbbVie said in a statement that the Food and Drug Administration said it would not meet the dates under the Prescription Drug User Fee Act for the applications for approval of Rinvoq, or upadacitinib, as a treatment for active psoriatic arthritis and active ankylosing spondylitis in adults.

The Prescription Drug User Fee Act allows the FDA to collect fees from drug manufacturers to fund the new drug approval process.

The FDA cited its ongoing review of Pfizer's  (PFE) - Get Free Report post-marketing study, ORAL Surveillance, evaluating tofacitinib in patients with rheumatoid arthritis, as the reason for not meeting the dates, AbbVie said.

"Rinvoq has demonstrated strong efficacy data, a safety profile that is well characterized from large long-term studies and a favorable benefit-risk profile," Michael Severino, AbbVie' vice chairman and president, said in a statement. "We remain committed to working with the FDA to bring Rinvoq to patients living with psoriatic arthritis, ankylosing spondylitis and other immune-mediated diseases."

In March, AbbVie said the FDA asked for a three-month extension to its New Drug Application after receiving requests for more information and an updated benefit-risk profile for the use of Rinvoq.

Earlier this month, AbbVie took questions from the Senate Finance Committee chairman on how it loses money in the U.S. and posts profit overseas.

In April, the company posted first-quarter earnings that beat Wall Street's expectations and also raised its full-year outlook amid stronger-than-expected sales of its therapeutic drugs and treatments.

AbbVie said at the time that global sales of Rinvoq came in at $303 million.

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