1. Pink Sheet

Pfizer’s Tofacitinib Clears FDA Without Limited Indication

 
• By Mary Jo Laffler

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 has cleared Pfizer Inc.’s JAK inhibitor Xeljanz (tofacitinib) for rheumatoid arthritis without the limited indication suggested by the Arthritis Drugs Advisory Committee.

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