FDA & Reata Pharmaceuticals: Allow Individuals with Friedreich Ataxia Access to Omaveloxolone
74,070 individuals signed on to the FA Community Response letter requesting Reata Pharmaceuticals submit a New Drug Application (NDA) on an urgent basis and FDA consider approval of an NDA for omaveloxolone in FA based on the existing evidence from clinical trials.
FARA issued a Call to Action in the form of the FA Community Response letter asking individuals to sign-on in support of a request to FDA and Reata that they work together to approve omav for FA as quickly as possible. FARA shared the FA Community Response letter via our website, email lists and social media channels. Sign-on opportunity was open from January 5-20, 2021.
Click the buttons below to read the full petition and cover letter that were submitted to FDA and Reata Pharmaceuticals.
Community Petition Cover Letter
View the Submitted Petition
51 FA clinical experts and the investigators who participated in the MOXIe studies have provided a separate letter that discusses the clinical significance of the MOXIe trial and omav results.
Healthcare Provider Letter of Support
At the links below, you will find a copy of the FA Community Response Letter and 13 letters of support from FA and Ataxia organizations, writing on behalf of the FA patients they represent and joining FARA in making the request of FDA and Reata to urgently submit a marketing application, approve and provide access to omaveloxolone.
FA Community Response Letter
Letters from Advocacy Organizations
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