Mortality Signal For Pfizer's Xeljanz In Rheumatoid Arthritis Puts A Damper On JAK Class

Analyst speculates that risk of pulmonary embolism for a higher unapproved dose of Xeljanz in arthritis could trigger a label change for the same regimen in the drug's ulcerative colitis indication.

"Uncertainty Ahead” sign on a background of blue sky with clouds

The cardiovascular risks seen with a higher-than-approved dose of Pfizer Inc.'s Janus kinase (JAK) inhibitor Xeljanz in a long-term rheumatoid arthritis study required by the US FDA have cast a shadow over the drug's other indications and for the class overall.

Xeljanz (tofacitinib) has been approved by the FDA since 2012 at the dose of 5 mg twice daily for moderate-to-severe rheumatoid arthritis (RA) after inadequate response or intolerance to methotrexate

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Immunological

More from Therapy Areas