Sanofi has withdrawn all trials involving the investigational blood cancer drug fedratinib.
The France-based pharma company said the reason to pull fedratinib – also known as SAR302503 – was due to the drug’s link to an increased risk of the brain disorder Wernicke’s encephalopathy.
The US Food and Drug Administration (FDA) has previously directed Sanofi to put on hold all clinical trials involving fedratinib after some patients involved in the study developed Wernicke’s encephalopathy, which can result in eye problems, loss of coordination and memory loss.
However, a subsequent analysis carried out by Sanofi in consultation with the FDA and other experts determined that the benefits posed by the drug did not outweigh its risk, forcing all development to be cancelled and all filing plans to be shelved.
Dr Tal Zaks, head of development and interim head of Sanofi Oncology, explained: “We are deeply disappointed to have to discontinue development of fedratinib, especially given the needs of this difficult-to-treat patient population and the earlier promise shown for this therapy, but patient safety is our top priority and drove this decision.”
Fedratinib – a JAK2 inhibitor – had been in development for several blood cancers that fall under the banner of myeloproliferative neoplasms.
The most advanced indication was myelofibrosis for which the drug had shown positive phase III data and was on course to compete with the likes of Gilead Sciences’ CYT387 and Cell Therapeutics/Baxter’s pacritinib.
The other blood disorders fedratinib is no longer being investigated for are polycythemia vera and essential thrombocythemia.
Sanofi said that patients currently in fedratinib trials should consult with their doctor to determine the best alternative course of therapy.