First Medication to Treat FA

First Medication to Treat Friedreich’s Ataxia Approved by the FDA

Yesterday, the U.S. Food and Drug Administration (FDA) announced the approval of SKYCLARYS (omaveloxolone) manufactured by Reata Pharmaceuticals, Inc., Plano, TX 75024 USA for the treatment of Friedreich’s Ataxia in adults and children 16 years of age and older (FDA statement).

Friedreich’s ataxia (FA) is a genetic, progressive, neurodegenerative movement disorder caused by mitochondrial dysfunction affecting 1 in 50.000 people in the US.

SKYCLARYS is the first approved treatment for FA, a disease associated with mitochondrial dysfunction and an important step for all rare diseases where mitochondrial dysfunction plays a major part in the pathogenesis………..