JAK-Inhibitor Review Delays Spur Talk Of US FDA Panel Meeting On Class Safety

After Pfizer saw increased risks in a surveillance study of Xeljanz, three other products have also seen their user fee dates pushed back; if FDA were to convene an expert panel, it could lead to more consistent labeling across the class, as requested in a recent citizen petition.

Alarm clock
FDA reviews of new indications for JAK inhibitors are being slowed by safety concerns. • Source: Shutterstock

A slew of recent user fee date extensions for oral JAK1-inhibitors has prompted speculation that the US Food and Drug Administration might convene an advisory committee to vet safety concerns with the class.

Although product sponsors are not providing much in the way of details, the recent goal date extensions come in the wake of results from a long-term, postmarketing safety study that showed cardiovascular and malignancy

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