Fedratinib: Development discontinued

Sanofi discontinued development of fedratinib, which was in Phase III testing for myeloproliferative disorders, including PMF. Sanofi said that following a thorough risk-benefit analysis, it determined the safety risk of fedratinib outweighed its benefit. According to the pharma, FDA had placed a full clinical hold on all trials of fedratinib on Nov. 13 as a result of an undisclosed number of cases "consistent with Wernicke's encephalopathy" in patients receiving fedratinib. Sanofi is aware of 1 fatality, which occurred in a patient with a pre-existing brain metastasis in a study examining ventricular repolarization in patients with advanced solid tumors. ...