On August 3rd, the FDA’s Arthritis Advisory Committee (AAC) recommended the approval of Pfizer’s tofacitinib tablets for a new indication.
On August 3rd, the FDA’s Arthritis Advisory Committee (AAC) recommended the approval of Pfizer’s tofacitinib tablets for a new indication. The committee discussed supplemental new drug applications for XELJANZ (tofacitinib) tablets and XELJANZ XR extended release tablets for the treatment of adult patients with active psoriatic arthritis (PsA). Tofacitinib was first approved in 2012 at a dose of 5 mg, twice daily, to treat patients with moderate-to-active rheumatoid arthritis (RA) who did not respond to methotrexate or other non-biologic disease-modifying antirheumatic drugs. The extended release formulation was approved in 2016 at a dose of 11 mg daily.
The committee discussed the efficacy, safety and benefit-risk considerations of XELJANZ for the treatment of adults with active PsA, at the proposed dose of 5mg twice daily for XELJANZ and 11mg once daily for XELJANZ XR. At the conclusion of this meeting, 2 discussion questions and 3 voting questions were posed to the committee.
The committee voted 10 to 1 in favor of XELJANZ to treat adult patients with active psoriatic arthritis. The patient representative and temporary voting member, Diane Aronson, voted against approval and expressed concerned with the efficacy and safety; particularly the lack of inhibition of radiographic progression of the disease and infection risks.
The committee’s decision was based on demonstrated efficacy for signs and symptoms of the disease, including arthritis, enthesitis, dactylitis, and quality of life. Overall, the committee agreed with the demonstration of efficacy from the two placebo-controlled, phase III trials, which included over 800 PsA patients. They were generally comfortable with the safety results, noting that the safety profile was consistent with the current safety profile in RA patients. However, there were some concern among committee members with some adverse events and lack of evidence regarding inhibition of radiographic progression.
Known adverse effects include serious infections, malignancies, major adverse cardiovascular events, and herpes zoster. Members of the committee noted a clear risk of herpes zoster and encouraged the establishment of a strong risk mitigation program.
The totality of data did not provide substantial evidence that tofacitinib has an effect on radiographic progression, which has not been a consideration for approval of PsA drugs. Therefore, the committee warned against claims in the labeling to suggest that tofacitinib has a positive effect on radiographic progression in PsA patients, if the product were to be approved.
If approved by the FDA, tofacitinib would be the first Janus kinase (JAK) inhibitor to treat PsA. The agency is not obligated to follow its panel’s recommendation, but normally does so. The FDA’s decision on whether to approve XELJAANZ (tofacitinib) for PsA is anticipated by December 2017.
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