Panel Backs Pfizer’s Tofacitinib For RA, With Narrower Indication
This article was originally published in The Pink Sheet Daily
FDA’s Arthritis Advisory Committee said May 9 that Pfizer had worded the second-line indication too broadly, and indicated that a 5 mg dose is to be preferred, at least to begin with, due to safety concerns.
You may also be interested in...
Pfizer’s Xeljanz Could See Narrower Label And New REMS Due To CV And Malignancy Risks
The US FDA will ponder its regulatory options now that final data are in from a long-term postmarketing study showing tofacitinib is associated with a higher rate of major adverse cardiovascular events and malignancies compared with TNF-inhibitors.
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.
Pfizer’s Xeljanz In Psoriasis Does Best At Dose That Worried FDA
To be competitive in plaque psoriasis, Pfizer’s Xeljanz may need its higher dose – but it will have to convince FDA to approve a dose it rejected due to safety concerns in rheumatoid arthritis.