FA community- Call to action!
FARA has prepared a letter to send to the Food and Drug Administration (FDA) and Reata Pharmaceuticals. This letter requests that Reata 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. The full letter is available at curefa.org/advocacy.
We are inviting the entire FA community (individuals with FA, family, friends, caregivers, supporters, other rare disease advocates) to sign-on in support. The sign-on period will remain open until January 20, 2021 at 5pm (Eastern). Signers will be identified in the letter by their affiliation with the FA community, first name, and last initial. Responses to question 5 may be quoted in the letter. The final letter with signature names will be sent to Reata, the FDA, and will be posted on FARA’s website upon completion.
We, as the Hellenic Friedreich’s Ataxia, invite you to co-sign the FARA letter, “Omavaloxolone for FA based on existing data from clinical trials”, in order to all contribute to the promotion of the approval of the first drug for our disease and better quality of life for our patients.
The period that the letter will remain open for voting is January 20, 2021 at 5 p.m.
Below is the link with the letter to be voted.
Thank you all!