Sanofi Discontinues Fedratinib Development - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

Sanofi Discontinues Fedratinib Development

Untitled Document

Sanofi has decided to stop all clinical trials and cancel plans for regulatory filings for its investigational JAK2 inhibitor, fedratinib.

Following a risk-benefit analysis, including consultation with FDA, study investigators, independent expert neurologists, and neuroradiologists, 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. FDA directed Sanofi to put all fedratinib trials on clinical hold while the company investigated these cases. Sanofi took immediate action requesting that study investigators discontinue fedratinibtreatment for patients in the trials.

Sanofi has notified investigators of all ongoing fedratinib trials, as well as health authorities, of its decision to halt the trials.

Source: Sanofi


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Obama Administration Halts Attack on Medicare Drug Plans

Click here