PARIS Sanofi has halted all clinical trials and cancelled plans to seek regulatory approval of fedratinib, a drug in late-stage development against rare bone marrow cancers, due to safety concerns.
The decision follows recent reports of cases consistent with the neurological disorder Wernicke's encephalopathy in patients in the fedratinib trials, the French drugs group said in a statement on Monday.
Fedratinib is a so-called JAK2 inhibitor medicine that was in final Phase III tests for treating myelofibrosis, a rare cancer of the bone marrow. The disease can occur in people with no history of bone marrow problems - in which case it is called primary myelofibrosis - and also in people who have essential thrombocythaemia or polycythaemia vera.
Industry analysts had penciled in relatively modest financial forecasts for the specialist oncology medicine, with sales of $226 million seen in 2017, following an expected launch in 2014, according to consensus forecasts compiled by Thomson Reuters Pharma.
The U.S. Food and Drug Administration (FDA) directed Sanofi to put all fedratinib trials on clinical hold while the company thoroughly investigated the cases of Wernicke's encephalopathy.
Sanofi said it took immediate action requesting that study investigators discontinue fedratinib treatment for patients in the trials.
Patients in fedratinib trials should consult with their treating physician to determine the best alternative course of therapy for their myelofibrosis, it said.
(Reporting by Dominique Vidalon and Ben Hirschler; Editing by Louise Ireland)