The US FDA has approved Skyclarys for adults & adolescents aged ≥16yrs. with Friedreich’s ataxia. The approval was based on the (MOXIe) part 2 trial & post hoc propensity-matched analysis of the OLE (MOXIe) trial evaluating omaveloxolone (150mg) vs PBO
The (MOXIe) part 2 trial results showed lower mFARS scores over PBO @48wk., the PBO-corrected difference b/w the 2 groups were -2.41 points. In the OLE trial, improved mFARS scores after 3yrs. over untreated patients from FA-COMS natural history study
The company launched a patient services program & provides access to patients for Skyclarys treatment. The product is expected to be available in Q2’23 and received ODD, FTD & RPDD from the US FDA; ODD from the EC for Friedreich’s ataxia
Ref: Businesswire | Image: Reata Pharmaceuticals
Related Post:- Reata Reports Results of Omaveloxolone in P-II MOXIe Registrational Study for Patients with Friedreich’s Ataxia
