SKYCLARYS (Omaveloxolone) Pregnancy and Lactation Surveillance Program

The primary objective of the study is to assess the risks associated with pregnancy and maternal complications in women with Friedreich’s Ataxia (FA) exposed to omaveloxolone during pregnancy and/or lactation. The secondary objective is to assess the adverse effects on the developing fetus, neonate, and infant in women exposed to omaveloxolone during pregnancy and/or lactation.

This is a remote study that will be completed through the review of medical records.

Study Details:

Inclusion Criteria:

• Female Friedreich’s ataxia patients who are 16 and older
• Exposure to at least 1 dose of omaveloxolone per label at any time during pregnancy (12 days prior to conception to pregnancy outcome) and/or at any time during lactation (up to 1 year of infant age or weaning, whichever comes first)

FARA believes that there are many different approaches to treating Friedreich’s ataxia, and that it will require a cocktail approach of two or more treatments to slow, stop, reverse, and cure FA. Learn more about this treatment approach and explore the other approaches that are in the FA Drug Development pipeline.