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FDA Advisory Committee Recommends Approval of Xeljanz for PsA
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The FDA Arthritis Advisory Committee voted 10-1 today for recommending approval of the supplemental new drug application for tofacitinib in the treatment of adult patients with active psoriatic arthritis.
The meeting focused on two phase 3 placebo-controlled trials that investigated the efficacy and safety of tofacitinib 5 mg twice daily and 10 mg twice daily (Xeljanz, Pfizer Inc.), as well as one ongoing phase 3 open-label, long-term extension study. Results showed tofacitinib reduced signs and symptoms of psoriatic arthritis (PsA) and improved physical function, and had a safety profile consistent with the established safety profile in rheumatoid arthritis (RA), with no new safety signals identified. Tofacitinib has previously been approved for treatment of adult patients with moderately to severely active RA and who have had an inadequate response or intolerance to methotrexate.
Concerns about radiographic progression
Committee members noted that overall, tofacitinib effectively treated psoriatic arthritis; however, there were concerns about insufficient evidence provided regarding radiographic progression. While evidence about radiographic progression was not needed for the recommendation of approval, the committee stressed that Pfizer Inc. should not claim that tofacitinib can inhibit radiographic progression — a finding seen among patients treated with the drug for RA.
“We are trying to get [patients] to resume their daily activities and if we are giving them information that tells them ... that they do not need to be thinking about some of these other potential conflicts and impairments they could be getting, I am just concerned about what that would do without being properly explained. I just would not make that claim at all,” voting committee member Jennifer Horonjeff, PhD, said.
Risk mitigation
The committee also voiced several concerns about the risks found in the safety profile, with several members requesting Pfizer be active in improving awareness on the adverse events listed.
“I am at the presumption that [cardiovascular events] should be held to a higher burden of proof to safety, but I do not know if there is data to answer this,” James Katz, MD, a voting temporary committee member, said. “Clearly, I would think that it would be within the purview of this committee to suggest to the sponsor that ongoing pharmacovigilance includes specific measurement of these particular issues.”
Overall, the committee held that the risks found for patients with PsA were no different than those found among patients with other indications being treated with tofacitinib.
“I see it as a great opportunity for risk mitigation that the sponsor and the agency can take together, because we have a clear risk, we have a clear strategy for mitigating the risk and there is going to be a lot more people exposed to this drug with known risks, so let’s do something about it,” Daniel H. Solomon, MD, MPH, the committee chairperson, said.
In a statement, Pfizer Inc. noted that the company was pleased with the positive vote by the committee.
“This is an important step forward in the FDA regulatory process,” the statement noted. “Based on the body of evidence, we believe tofacitinib, if approved, has the potential to be an important additional treatment option that could help address an unmet need for those living with active psoriatic arthritis.” – by Casey Tingle
References:
Arthritis Advisory Committee Meeting. Thurs., Aug. 3, 2017. www.fda.gov/AdvisoryCommittees/Calendar/ucm566227.htm
Disclosure: The researchers report no relevant financial disclosures.