Disclosures: Severino reports employment relationship with AbbVie.
March 17, 2021
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FDA extends review period for expanded use of Rinvoq in PsA to assess risk-benefit

Disclosures: Severino reports employment relationship with AbbVie.
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The FDA has extended its review period for the supplemental new drug application of AbbVie’s upadacitinib for active psoriatic arthritis to allot more time to examine its risk-benefit profile, according to a company press release.

Currently approved for adult patients with moderate to severe rheumatoid arthritis who have responded inadequately or are intolerant to antirheumatic drugs, Rinvoq (upadacitinib) applications were submitted to both the FDA and European Medicines Agency in June 2020 to expand its usage for adults with PsA.

Sign outside FDA HQ in Washington, DC.
The FDA has extended its review period for expanded use of upadacitinib by three months, to allow additional time to review the drug’s risk-benefit profile. Source: Adobe Stock

The FDA extended the Prescription Drug User Fee Act goal date by 3 months to review additional data on the risk-benefit profile for upadacitinib in PsA submitted by AbbVie in response to the FDA’s information requests.

“We remain confident in the sNDA and are committed to working with the FDA to bring upadacitinib to patients living with psoriatic arthritis and other immune-mediated diseases,” Michael Severino, MD, vice chairman and president of AbbVie, said in the release.

The additional review of the drug’s risk-benefit profile may stem from a recent FDA safety alert regarding tofacitinib (Xeljanz, Pfizer), another JAK inhibitor, that has been linked to an increased risk for serious heart-related issues and cancer among older patients, compared with TNF inhibitors.

AbbVie received a similar request from the FDA related to the sNDA for upadacitinib in atopic dermatitis, which it plans to submit to the agency soon.