FDA extends review period for expanded use of Rinvoq in PsA to assess risk-benefit
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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.
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.
Perspective
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David A. McLain, MD, MACR, FACP, FRCP
The JAK world of new compounds and new indications is active at the FDA. Within the next month, Pfizer will be seeking approval for the use of tofacitinib in ankylosing spondylitis and abrocitinib in atopic dermatitis and AbbVie is seeking approval for the use of upadacitinib in atopic dermatitis and psoriatic arthritis; other JAKs being considered for atopic dermatitis are baricitinib (Incyte and Eli Lilly) and topical ruxolitinib (Incyte).
The JAK world was shaken by the recent Pfizer press release that tofacitinib failed to meet the noninferiority safety endpoint compared to TNF inhibitors (adalimumab or etanercept) with regards to major adverse cardiovascular events (MACE) and malignancies (excluding non-melanoma skin cancer).
The most common MACE was a myocardial infarction and the most common malignancy was lung cancer. The actual number of cases was low in all groups. The incident rates (IR) for adjudicated MACE were 0.73 for TNF inhibitors and 0.98 for tofacitinib. The IR for malignancy was 0.77 for TNF inhibitors and 1.13 for tofacitinib.
While the IRs were not that different, the non-inferiority endpoints were significantly different with both for tofacitinib exceeding the predetermined confidence interval of 1.8. This is all the data in the public domain on this issue to date. It is expected that the FDA will increase scrutiny on the JAKs because of these findings.
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