FDA Fast-Tracks Friedreich's Ataxia Drug
The Friedreich’s Ataxia (FA) community received even MORE great news today!
Edison Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Status to EPI-743 for the treatment of Friedreich’s Ataxia. This status will further accelerate the clinical development of EPI-743 now under way in two phase 2b clinical trials at three sites in the Friedreich's Ataxia Research Alliance (FARA) Collaborative Clinical Research Network.
When the FDA grants the Fast Track designation, the Agency encourages early and more frequent meetings and communications with the drug company throughout the drug development and review process to ensure that any questions and issues are resolved quickly. With this status, the drug may also benefit from "rolling review," which permits the drug company to submit completed portions of its application for approval (New Drug Application) for immediate review by the FDA, instead of waiting for the entire application to be completed. These multiple benefits are intended to result in substantially faster drug approval and earlier treatment access by patients.
For the full FARA press release, please go here.