With a sizeable post-marketing safety study review complete, the U.S. Food and Drug Administration (FDA) concludes that risks for significant heart-related events, from myocardial infarction and stroke to greater risks for cancer, clotting, and even death, suggest considerable forthcoming changes in labels for tofacitinib, marketing as Xeljanz and Xeljanz XR, a drug type known as JAK Inhibitors.
TrialSite provides a brief summary breakdown for the community.
What’s the drug’s background?
JAK inhibitor commercialization is the result of a partnership between the National Institutes of Health and Pfizer. As opposed to a biologic, a small molecule drug interferes with the JAK-STAT signaling pathway, which is transmitting extracellular information into the cell nucleus and thus influencing DNA transcription.
Who is the drug’s developer?
What are annual revenues?
Pfizer generated approximately $2.4 billion from this drug in 2020, bringing it into Blockbuster status.
What is the drug used for?
The drug is used primarily for rheumatoid arthritis, as well as psoriatic arthritis and ulcerative colitis.
What are common side effects?
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