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 posted on FARA's website upon completion.

Email address *

First Name *

Last Name *

1. Please indicate your country of residence. *

United States

Other:

1a. If you reside in the United States, please select your state or territory.

2. Please indicate your affiliation with the FA Community. I am: *

Living with FA

A Parent or family member of an individual with FA

A Parent or family member of an individual who died with FA

A friend to the FA community, an advocate, and/or a volunteer

A Healthcare provider (Note: there is a separate letter that FA clinician researchers have prepared which will be available soon)

Caregiver

A Researcher or scientist

An Advocacy Organization (I have authority to sign on behalf of my organization.)

Other:

3. If you or your child have FA, what is your / your child’s age?

4. Which of the following best describes your /your child’s stage of disease with FA?

Newly diagnosed – 0-2 yrs from symptom onset and diagnosis

Been living with symptoms of FA for 2-8 years and/or able to perform most activities of daily living independently

Been living with symptoms of FA for 8-14 years and/or require assistance with activities of daily living

Been living with symptoms of for >15 years and/or require assistance with all activities of daily living

Clear selection

5. If you or your immediate family member has or had FA, please respond to this question. Based on the data currently available on safety and efficacy of omaveloxolone would you, your child and/or your family member want the option of taking the drug/medicine? Please explain your response. If you participated in the MOXIe part 1, part 2 or open label extension study, please feel free to share your experience or observations.

A copy of your responses will be emailed to the address you provided.

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