Omaveloxolone (1 brand name, 1 dosage form, 1 route)
Available dosage forms: CAPSULE.
Routes of administration: ORAL.
Brand Names
- SKYCLARYS
Indications and Usage
SKYCLARYS is indicated for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older.
Contraindications
None.
Adverse Reactions
The following clinically significant adverse reactions are described in greater detail in other labeling sections: Elevation of aminotransferases [see Warnings and Precautions (5.1)] Elevation of BNP [see Warnings and Precautions (5.2)] Lipid abnormalities [see Warnings and Precautions (5.3)]
Mechanism of Action
The precise mechanism by which omaveloxolone exerts its therapeutic effect in patients with Friedreich’s ataxia is unknown. Omaveloxolone has been shown to activate the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway in vitro and in vivo in animals and humans. The Nrf2 pathway is involved in the cellular response to oxidative stress.