Letter to FDA & Reata Pharmaceuticals regard Access to Omaveloxolone
A Call to Action was held from January 5, 2021 – January 20, 2021 where the entire FA community (individuals with FA, family, friends, caregivers, supporters, other rare disease advocates) to sign-on a letter to the Food and Drug Administration (FDA) and Reata Pharmaceuticals. This letter requests Reata to submit a New Drug Application (NDA) on an urgent basis and the FDA to exercise the flexibility granted by law and contained in the FDA guidance in considering approval of an NDA for Omaveloxolone in FA based on the existing evidence from clinical trials.