February 28, 2023—Rare Disease Day—marked the FDA approval of SKYCLARYS (omaveloxolone), the first approved treatment for Friedreich’s ataxia (FA). I am thrilled to celebrate this huge milestone with you all. Thanks to your unwavering dedication and support of FA research, patients in the US who are 16 years of age or older will never need to hear “we have no approved treatment for FA” again. We look forward to continued collaboration with Reata, FDA, and other regulatory agencies to expand access to broaden that group to include all FA patients regardless of age or location.
We are hopeful that this is the first of several approved therapies for FA. FARA has always known that treating FA would require a cocktail approach of therapies to ultimately slow, stop, and reverse FA. As expected with the first of anything, there are many questions that follow. In this monthly update, we have shared some resources to help you navigate this new drug approval and learn more about omaveloxolone's mechanism of action. We are excited that there is an established path to approval, and we remain committed to bringing effective therapies forward for all people living with FA.
FARA Chief Executive Officer
Other topics in our March Monthly update:
- Omav Approval Information and Resources
- Open & Enrolling Studies
- Two-Minute Mechanisms - Episode 1: Omaveloxolone
- Research Receptions
- Upcoming Events
- Join the Registry Today!