<p>Skyclarys is a medicine used in patients aged 16 years and older to treat Friedreich’s ataxia, an inherited disease that causes damage to the nervous system, resulting in difficulties with coordination, balance and movement, fatigue, difficulty speaking, as well as an increased risk of cardiomyopathy (damage to the heart muscle) and diabetes.</p><p>Friedreich’s ataxia is rare, and Skyclarys was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 27 June 2018. Further information on the orphan designation can be found on the EMA <a href="https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-18-2037"><u>website</u></a>.</p><p>Skyclarys contains the active substance omaveloxolone.</p>
Therapeutic Indication
<div class="subsection mt-3-5"> <h3>Therapeutic indication</h3><p>The treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older.</p> </div>
Therapeutic Area (MeSH)
ATC Code
N07XX25
ATC Item
N/A
Pharmacotherapeutic Group
Other nervous system drugs
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| omaveloxolone | N/A | omaveloxolone |
EMA Name
Skyclarys
Medicine Name
Skyclarys
Aliases
N/ANo risk management plan link.