The FDA could approve the first treatment for Friedreich’s ataxia, and at least three other major trials have readouts expected by year end.
All signs indicate 2023 will prove a pivotal year in Friedreich’s ataxia drug development. Reata’s omaveloxolone, which met its primary endpoint in a Phase II trial, is up for FDA approval on February 28. Meanwhile, a Phase II/III trial of PTC’s vatiquinone, a Phase I/II trial of Stealth Bio’s elamipretide, and a Phase II study of Larimar’s CI-1601 all have key results expected in 2023.
Thursday, December 1, 2022
Friedreich’s ataxia: major trial readouts and regulatory events to watch in 2023
www.clinicaltrialsarena.com; Analysis. November 30, 2022
