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Pfizer: FDA might delay approval of rheumatoid arthritis drug
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The FDA recently requested additional analysis of existing data on tofacitinib, a proposed rheumatoid arthritis drug from Pfizer, the drug maker announced this week.
Pfizer plans to provide the FDA with the information early this month and anticipates that regulators might require additional time beyond tofacitinib’s Aug. 21 Prescription Drug User Fee Act date, possibly delaying final approval, the company said in a news release.
The FDA Arthritis Advisory Committee voted 8-2 on May 9 in favor of the Janus kinase 3-inhibitor as a treatment for patients with rheumatoid arthritis (RA).
The drug was proposed with a starting dose of 5 mg twice daily for patients with moderately to severely active RA who have had inadequate response to at least one disease-modifying anti-rheumatic drug. The proposed dosage could be increased to 10 mg based on clinical response.
Pfizer also announced that in a recent study, tofacitinib “was found to be superior” to methotrexate (MTX) in inhibiting structural damage and reducing signs and symptoms of RA. According to the news release, the study randomized 958 MTX-naive patients with moderate to severe RA to receive tofacitinib monotherapy in 5 mg or 10 mg twice daily or MTX; no new safety signals emerged. Pfizer said it plans to submit details of the study at a future scientific meeting.