Reactions 1480, p2 - 30 Nov 2013

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Clinical development of fedratinib discontinued Clinical development of fedratinib has been discontinued, according to a press release from Sanofi. The decision to halt all clinical trials and cancel plans for regulatory filings with fedratinib followed recent reports of cases consistent with Wernicke’s encephalopathy in patients who participated in fedratinib clinical trials. The US FDA directed Sanofi to put all fedratinib trials on hold while the company investigated these cases. Fedratinib (SAR302503) is a novel, investigational JAK2 inhibitor that was under development for the treatment of myeloproliferative neoplasms, such as primary myelofibrosis. Following a thorough risk-benefit analysis, including consultation with the study investigators, independent expert neurologists and neuroradiologists, as well as the FDA, Sanofi determined that the risk to patient safety outweighed the benefit of fedratinib treatment. Sanofi requested that study investigators discontinue fedratinib treatment for patients in the trials. Sanofi. Sanofi Discontinues Clinical Development of Investigational JAK2 Agent Fedratinib (SAR302503). Media Release : 18 Nov 2013. Available from: URL: 809156618 http://en.sanofi.com

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Reactions 30 Nov 2013 No. 1480