FA Community Call to Action
FDA & Reata Pharmaceuticals: Allow Individuals with Friedreich Ataxia Access to Omaveloxolone
FARA prepared a letter to send to the Food and Drug Administration (FDA) and Reata Pharmaceuticals. This letter requested Reata to submit a New Drug Application (NDA) on an urgent basis and FDA to exercise the flexibility granted by law and contained in FDA guidance in considering approval of an NDA for Omaveloxolone in FA based on the existing evidence from clinical trials.
We invited the entire FA community (individuals with FA, family, friends, caregivers, supporters, other rare disease advocates) to sign-on in support. The sign-on period was open from the evening of January 5-January 20, 2021 at 5pm (Eastern). The FARA staff will compile the shared signatures and comments into one report for the FDA and Reata Pharmaceuticals. Once that document is complete, it will be posted here.
Read The Letter...
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