SKYCLARYS is indicated for the treatment of Friedreich ataxia in adults and adolescents aged 16 years and older.1
Get patients started with SKYCLARYS
The first and only FDA-approved prescription medicine for Friedreich ataxia in patients 16 years and older.1,2
References:
1. Skyclarys. Prescribing Information. Biogen; 2024.
2. Lynch DR, Chin MP, Delatycki MB, et al. Safety and efficacy of omaveloxolone in Friedreich ataxia (MOXIe study). Ann Neurol.
2021;89(2):212-225. doi:10.1002/ana.25934 3. Parkinson MH, Boesch S, Nachbauer W, Mariotti C, Giunti P. Clinical
features of
Friedreich’s ataxia: classical and atypical phenotypes. J Neurochem. 2013;126(suppl 1):103-117. doi:10.1111/jnc.12317 4.
Schulz
JB, Boesch S, Bürk K, et al. Diagnosis and treatment of Friedreich ataxia: a European perspective. Nat
Rev
Neurol. 2009;5(4):222-234. doi:10.1038/nrneurol.2009.26 5. Rummey C, Farmer JM, Lynch DR. Predictors of loss of
ambulation in
Friedreich’s ataxia. eClinicalMedicine. 2020;18:1-9. doi:10.1016/j.eclinm.2019.11.006 6. Rummey C, Corben LA,
Delatycki MB, et al.
Psychometric properties of the Friedreich Ataxia Rating Scale. Neurol Genet. 2019;5(6):371. doi:10.1212/NXG.0000000000000371
7. Patel M,
Isaacs CJ, Seyer L, et al. Progression of Friedreich ataxia: quantitative characterization over 5 years.
Ann
Clin Transl Neurol. 2016;3(9):684-694. doi:10.1002/acn3.332 8. Lynch DR, Chin MP, Boesch S, et al.
Efficacy of omaveloxolone in
Friedreich’s ataxia: delayed-start analysis of the MOXIe extension. Mov Disord. 2023;38(2):313-320. doi:10.1002/mds.29286 9. Galea CA, Huq A, Lockhart PJ, et al. Compound
heterozygous FXN
mutations and clinical outcome in Friedreich ataxia. Ann Neurol. 2016;79(3):485-495. doi:10.1002/ana.24595
10. Fogel BL, Perlman
S. Clinical features and molecular genetics of autosomal recessive cerebellar ataxias. Lancet
Neurol.
2007;6(3):245-257. 11. Wallace SE, Bird TD. Molecular genetic testing for hereditary
ataxia: what every
neurologist should know. Neurol Clin Pract. 2018;8(1):27-32. doi:10.1212/CPJ.0000000000000421 12. Data on file. Reata Pharmaceuticals, Inc.; 2022. 13.
Lynch DR, Goldsberry A, Rummey C, et al. Propensity matched comparison of omaveloxolone treatment to Friedreich ataxia natural history data. Ann Clin Transl Neurol. 2024;11(1):4-16. doi:10.1002/acn3.51897 14.
Beaulieu-Jones BK, Finlayson SG, Yuan W, et al. Examining the use of real-world evidence in the regulatory process. Clin Pharmacol Ther. 2020;107(4):843-852. doi:10.1002/cpt.1658