Jan. 21, 2025 — Today, Solid Biosciences announced that it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for SGT-212, the company’s AAV-based gene therapy candidate for the treatment of Friedreich’s ataxia (FA). SGT-212 will deliver the full-length frataxin gene via dual routes of administration incorporating intradentate nucleus (IDN) and intravenous (IV) infusions, designed to promote restoration of therapeutic levels of the frataxin protein to address neurologic, cardiac and systemic clinical manifestations of FA.
Fast Track designation is granted to products that are developed to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. This designation is intended to facilitate development and expedite review of qualifying drugs. SGT-212 will benefit from this designation by having more frequent interactions with the FDA and the potential to be eligible for priority review.