Sanofi has decided to stop all clinical trials and cancel plans for regulatory filings for its investigational JAK2 inhibitor, fedratinib.
Following a risk-benefit analysis, including consultation with FDA, study investigators, independent expert neurologists, and neuroradiologists, Sanofi determined that the risk to patient safety outweighed the benefit that fedratinib would bring to patients.
This decision follows recent reports of cases consistent with Wernicke’s encephalopathy in patients participating in fedratinib clinical trials. FDA directed Sanofi to put all fedratinib trials on clinical hold while the company investigated these cases. Sanofi took immediate action requesting that study investigators discontinue fedratinibtreatment for patients in the trials.
Sanofi has notified investigators of all ongoing fedratinib trials, as well as health authorities, of its decision to halt the trials.