Celebrex Gets Thumbs Up For Kids, But Cmte. Wants Follow-Up
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA’s Arthritis Advisory Committee urges Pfizer to create an active surveillance program to track potential safety issues from the use of the COX-2 inhibitor for juvenile rheumatoid arthritis.
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FDA's Arthritis Advisory Committee recommended approval of Pfizer's Celebrex for treatment of juvenile rheumatoid arthritis Nov. 29. The committee voted 15 to one that the risk/benefit ratio of the COX-2 inhibitor supports approval for the pediatric indication despite voicing reservations about long-term safety issues. Pfizer's sNDA is supported by a single non-inferiority study comparing 12 mg and 6 mg Celebrex (celecoxib) to 15 mg naproxen in 242 children with juvenile rheumatoid arthritis (JRA). The committee unanimously agreed that the study demonstrates that Celebrex is effective and would provide an additional non-steroidal anti-inflammatory treatment option prior to initiation of more toxic therapies. However, the panel voted eight to seven with one abstention that existing data do not establish celecoxib's safety for the desired indication. The committee was particularly concerned about a lack of long-term safety data for a therapy used to treat a chronic condition. The committee therefore agreed that passive adverse event reporting was insufficient to address the potential long-term safety risks of celecoxib use for JRA. As a condition of its recommendation for approval, the committee asked for a strengthened postmaketing surveillance program, suggesting a registry that would track safety issues such as gastrointestinal and cardiovascular events. In its briefing documents, FDA also expressed concern about the lack of long-term data for the indication (1 (Also see "Celebrex JRA Indication To Be Evaluated By FDA Advisory Committee" - Pink Sheet, 28 Nov, 2006.)). -Brian Marson ([email protected]) |