Pfizer’s Tofacitinib Clears FDA Without Limited Indication
This article was originally published in The Pink Sheet Daily
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.
You may also be interested in...
Arthritis Advisory Committee members say the company should bear some of the responsibility for managing the risk of shingles with the JAK inhibitor.
The oral pill, perhaps best known to investors for failing to live up to initial expectations in rheumatoid arthritis, has found its groove – and new opportunities in psoriatic arthritis and ulcerative colitis are on the horizon.
Xeljanz’s launch in rheumatoid arthritis has gotten off to a slower than expected start, highlighting the challenges for new drugs in competitive inflammatory diseases. But Pfizer is digging in its heels and hoping that pipeline drugs, including next-generation JAKs, will stand out by addressing unmet medical need in indications like lupus, type1 diabetes and inflammatory bowel disease.