Sanofi discontinues clinical development of investigational JAK2 agent Fedratinib (SAR302503)

Press release from Sanofi issued 18th November 2013 regarding the decision to halt all clinical trials and development of investigational JAK2 Agent Fedratinib (SAR302503)

Sanofi (EURONEXT: SAN and NYSE: SY) have announced their decision to halt all clinical trials and cancel plans for regulatory filings for the investigational JAK2 inhibitor fedratinib (SAR302503). This is following a risk-benefit analysis following recent reports of cases consistent with *Wernicke’s encephalopathy in patients participating in fedratinib clinical trials.

The press release is available here mpdvoice.org.uk/wp-content/...

Fedratinib is a novel, investigational JAK2 inhibitor that was under development for the treatment of the three main types of MPNs (myeloproliferative neoplasms): primary myelofibrosis (including those patients previously treated with Ruxolitinib) polycythaemia vera and essential thrombocythaemia.

If you are currently in a fedratinib trial you should have been contacted by your haematologist/physician who will determine the best alternative therapies available to you.

If you have any concerns regarding fedratinib please contact your haematologist.

*Wernicke’s encephalopathy – mental confusion or delirium occurring in combination with paralysis of the eye muscles, nystagmus and an unsteady gait.

5 Replies

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  • Thanks Maz, such a shame it's not worked out. I wish everyone on the trial good luck in finding a good alternative.

  • Do you know what is the reason for stopping this trial for JAK2??

  • Hi Light, it's because there have been some cases of people on the trial suffering with Wernicke’s encephalopathy – mental confusion or delirium occurring in combination with paralysis of the eye muscles, nystagmus and an unsteady gait, therefore the trial has been stopped while investigations are carried out. Maz

  • Thanks Maz, it is good to know that. Do you have any more of information on that investigations? How long they are going to go with it and whether they will share findings from that investigation and would that be available to us??

  • Hi Light, I'm sorry but I don't know any more than has been published in the press release, as per the link in my post above, as soon as any further information is released I will let you know.

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