Trials & Filings

Sanofi Cancels JAK2 Development

Encephalopathy events take down myelofibrosis compound

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Sanofi has halted all clinical trials and has canceled plans for regulatory filings for  its investigational JAK2 inhibitor, fedratinib (SAR302503). The move follows a thorough risk-benefit analysis, including consultation with the FDA, study investigators, independent expert neurologists and neuro-radiologists. There have been recent reports of cases consistent with Wernicke’s encephalopathy in patients participating in fedratinib clinical trials, which led the FDA to direct Sanofi to put all ...

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