赛诺菲终止fedratinib临床开发

赛诺菲（Sanofi）11月18日宣布，将停止有关实验性JAK2抑制剂fedratinib（SAR302503）的所有临床试验，同时取消提交相关监管申请的计划。

经过一项彻底的风险-效益（risk-benefit）分析，包括与FDA、研究人员、独立的神经学专家和神经放射科医师的讨论，赛诺菲确定，fedratinib带给患者的安全性风险，超过了该药可能带来的临床益处。

这一决定源于最近的个例报道，参与fedratinib临床试验的患者组中，出现了与韦尼克脑病（Wernicke′s encephalopathy，WE）相一致的症状。FDA已要求赛诺菲停止所有有关fedratinib的临床试验，同时赛诺菲将彻查这些个例，以确保fedratinib对于患者的安全性。赛诺菲已立即采取行动，要求研究人员停止对临床试验的患者给予fedratinib治疗。

关于fedratinib：

Fedratinib是一种新颖的、实验性JAK2抑制剂，开发用于治疗3种主要类型的骨髓增殖性肿瘤：原发性骨髓纤维化、真性红细胞增多症、原发性血小板增多症。

Sanofi Discontinues Clinical Development of Investigational JAK2 Agent Fedratinib

Paris, France – November 18, 2013 – Sanofi (EURONEXT: SAN and NYSE: SNY) announced today the decision to halt all clinical trials and cancel plans for regulatory filings with its investigational JAK2 inhibitor, fedratinib (SAR302503). 

Following a thorough risk-benefit analysis, including consultation with the U.S. Food and Drug Administration (FDA), study investigators, independent expert neurologists and neuro-radiologists, Sanofi determined that the risk to patient safety outweighed the benefit that fedratinib would bring to patients.

This decision follows recent reports of cases consistent with Wernicke’s encephalopathy in patients participating in fedratinib clinical trials. The FDA directed Sanofi to put all fedratinib trials on clinical hold while the company thoroughly investigated these cases to ensure the safety of fedratinib for patients. Sanofi took immediate action requesting that study investigators discontinue fedratinib treatment for patients in the trials.

“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,” said Tal Zaks, MD, PhD, VP, Head of Development and Interim Head of Sanofi Oncology.

Sanofi has notified investigators of all ongoing fedratinib trials, as well as health authorities, of its decision to halt the trials. Patients currently in fedratinib trials should consult with their treating physician to determine the best alternative course of therapy for their myelofibrosis.

About fedratinib (SAR302503)

Fedratinib is a novel, investigational JAK2 inhibitor that was under development by Sanofi Oncology for the treatment of the three main types of myeloproliferative neoplasms: primary myelofibrosis, including those previously treated with ruxolitinib; polycythemia vera; and essential thrombocythemia.