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FDA Warnings And Restrictions On JAKs Curb Growth Potential Of Big Brands

 
• By Jessica Merrill

Pfizer, AbbVie and Lilly will face new safety restrictions on Xeljanz, Rinvoq and Olumiant. Indication expansion remains uncertain, while first-line use appears out of the question.

Caution tape
FDA put new warnings on JAK inhibitors for inflammatory conditions • Source: Alamy

The US Food and Drug Administration's concerns over the safety of Pfizer Inc.'s Xeljanz and Xeljanz XR (tofactinib) will result in new warnings and restrictions that will extend to the entire class of Janus kinase (JAK) inhibitors for rheumatoid arthritis and other inflammatory conditions, posing new commercial challenges for several key growth brands.

The agency announced the results of a months-long safety review of Xeljanz on 1 September, concluding there is an increased risk of serious heart-related events such as heart attack,

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