FDA fast tracks Friedreich’s ataxia drug undergoing testing in USF-led trial
The U.S. Food and Drug Administration yesterday designated fast-track status to EPI-743 for the treatment of Friedreich’s ataxia – a move that will help accelerate clinical development of the investigational drug, currently being tested in a multisite, double-blind, placebo-controlled trial led by the University of South Florida.
The phase 2b clinical trial of EPI-743 in adults with Friedreich’s ataxia, sponsored by Edison Pharmaceuticals, Inc., in collaboration with the Friedrich’s Ataxia Research Alliance, has been underway since early 2013 at the USF Health, the Children’s Hospital of Philadelphia and the University of California in Los Angeles. Neurologist Theresa Zesiewicz, MD, director of the USF Ataxia Research Center, is the lead investigator for the national trial.
Researchers are primarily testing the effectiveness of EPI-743, a potent antioxidant, on vision, in patients with Friedreich’s ataxia, many of whom experience varying degrees of visual changes. Secondarily, the study is evaluating neurological function.
For more on the fast track status of EPI-743, go to: http://www.firstwordpharma.com/node/1195801#axzz2wKgT2a1W