Following talks with FDA, Sanofi drops fedratinib development

18 November 2013

French drug major Sanofi (Euronext: SAN) this morning (November 18) revealed its decision to halt all clinical trials and cancel plans for regulatory filings with its investigational Janus kinase (JAK)2 inhibitor, fedratinib (SAR302503), in development for myelofibrosis (MF), a rare type of blood cancer. Shares of Sanofi were barely changed in early morning trading, falling just 0.3% to 79.60 euros.

Following a thorough risk-benefit analysis, including consultation with the US Food and Drug Administration study investigators, independent expert neurologists and neuro-radiologists, Sanofi determined that the risk to patient safety outweighed the benefit that fedratinib would bring to patients.

Move follows cases of encephalopathy

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