India’s Drug Advisory Body Calls For Larger Study To Approve Pfizer’s Xeljanz
This article was originally published in PharmAsia News
The New Drug Advisory Committee said the number of patients enrolled in Pfizer’s Xeljanz trials was not statistically significant to recommend marketing authorization.
You may also be interested in...
The EMA has rejected Pfizer’s tofacitinib for the second time on safety grounds and Otsuka’s delamanid due to a short trial length.
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.
A rising number of enforcement actions by major drug regulators like the U.S. FDA is slowly making investors cautious about the longer term repercussions on earnings of Indian drug makers.