Pfizer’s Xeljanz In Psoriasis Does Best At Dose That Worried FDA
This article was originally published in The Pink Sheet Daily
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.
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Sandoz has begun a global Phase III trial with its biosimilar version of Amgen's Enbrel (etanercept), targeting psoriasis rather than the more lucrative indication for rheumatoid arthritis, with the aim of winning quicker regulatory approval which can be built on as it gains insights testing the medicine.
With FDA’s early approval of tofacitinib for rheumatoid arthritis – the first JAK inhibitor and, unlike the popular TNF inhibitors, an oral agent – the agency appears to have sided with Pfizer on many issues left up in the air after an advisory committee review.
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.