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Tofacitinib Data Is In: As Effective As Humira, But Safety Remains A Question

Executive Summary

Pfizer Inc. on Sept. 8 released some data from three previously undisclosed pivotal trials for tofacitinib, its high-profile, first-in-class JAK3 inhibitor for rheumatoid arthritis, which it says shows that the drug is equal in efficacy to Abbott Laboratory Inc.’s bestselling TNF inhibitor Humira.

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Definitive data on structural damage measurement can be collected post-market, FDA’s Arthritis Advisory Committee said in voting to support approval. But the panel and FDA were both troubled by uncertainties over the safety profile, especially because the rheumatoid arthritis therapy would be for chronic use.

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“We see the whole market really changing over the next 10 years to reflect more and more use of mechanisms other than anti-TNFs,” Sue Dillon says.

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The marketability and even the approvability of the first-in-class JAK inhibitor for treatment of rheumatoid arthritis may hinge on whether it can be shown to offer patients a structural benefit. FDA briefing documents for the May 9 advisory committee review show issues with those findings.

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