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FDA Approves First Treatment for Friedreich’s Ataxia

March 2, 2023

The FDA recently the FDA announced approval for SKYCLARYS (omaveloxolone) for the treatment of Friedreich’s Ataxia. This is the first and only FDA-approved prescription medicine for Friedreich’s Ataxia. NAF is thrilled about this announcement and proud to have been involved in the process, from clinical trial recruitment to educating our community about the drug development process and how treatments for Ataxia will be accessed. Thank you to all the FA patients who participated in research to make this possible! Read Reata Pharmaceutical’s full press release for more details.

How Can I Get SKYCLARYS?

According to the approved label, SKYCLARYS is a once-daily oral medication indicated for the treatment of Friedreich’s Ataxia in adults and adolescents aged 16 years and older. A patient/caregiver website for SKYCLARYS is available at www.SKYCLARYS.com. Visit the SKYCLARYS patient website to learn more, then speak with your physician to determine if it is a good option for you.

Reata's REACH Program

Reata also announced the launch of Reata Education, Access, and Care Helpline (REACH). The REACH Patient Center is an informational resource for you and your caregivers to explore ways to access prescribed Reata medicines. For additional information about REACH programs call 1-844-98-REACH or visit www.reataREACH.com.

Rare Disease Medication FAQ

Obtaining SKYCLARYS requires the use of a specialty pharmacy. This means that your prescribing doctor will need to follow a process to fill your prescription. FARA investigated how the process has worked for other rare diseases. They created this helpful FAQ about how to access a new medication for a rare disease after the FDA has approved it. This FAQ is not specific to SKYCLARYS, but will help educate you on the process of using a specialty pharmacy.