FDA Panel To Weigh Unmet Need Vs. Liver Injury With Samsca Kidney Indication
This article was originally published in The Pink Sheet Daily
Risk of drug-induced injury is likely to complicate an Aug. 5 advisory committee review of Otsuka’s kidney drug tolvaptan.
You may also be interested in...
FDA advisory committee briefing docs indicate odds stacked against Otsuka’s tolvaptan kidney disease indication without better efficacy data to counteract drug-induced liver injury risk.
There is a new category of FDA action letter: a REMS release. Dozens of sponsors of “MedGuide-only” REMS received them after an FDA policy change. But now, FDA is issuing them regularly to sponsors whose communication plans have met their goals – or at least run their course.
Agency officials, industry and academia contemplate a new approach to gauging drug-induced liver injury by using individual patients’ baseline liver enzyme measurements, a move that some say could eliminate problems with the use of the upper limit of normal and allow for the assessment of DILI in cases where there is underlying liver injury.