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Sanofi Halts Development of Blood Cancer Drug

Sanofi has halted all clinical trials and is discontinuing development for its blood cancer drug fedratinib (SAR302503) due to a link between the drug and an increased risk of the brain disease Wernicke’s encephalopathy.

FDA Probes Fedratinib Trials

According to PMLive, the FDA had previously ordered Sanofi to place a partial hold on clinical trials for fedratinib after discovering a relationship between the experimental cancer drug and the brain disorder.

However, follow-up analysis by the FDA, Sanofi and independent experts suggested that the risks associated with the drug outweighed the benefits resulting in Sanofi decision to scrap all development for the drug and shelf any filing plans indefinitely.

The drug was in development as a possible treatment for several types of blood cancer including phase III trials for myelofibrosis and early stage trials for polycythemia vera and essential thrombocythemia.

About Wernicke’s Encephalopathy

  • Wernicke’s encephalopathy, also known as Wernicke’s disease, is a brain disorder which can lead to vision and eye problems, loss of coordination and memory loss.
  • The disease is estimated to affect around 2 percent of the world’s population, and is most often associated with alcohol abuse in malnourished individuals.
  • Physicians may have trouble positively diagnosing Wernicke’s encephalopathy as a patient may only exhibit a few of the symptoms associated with the disease.
  • Patients who participated in clinical trials for fedratinib are urged to consult with their physicians should they experience changes in vision, impaired memory, confusion or changes in personality.
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