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FDA Approval Letter – Omaveloxolone
The deadline to sign this letter was this past Wednesday, January 20th. Over the past two weeks, people living with FA, their family members, their friends, their healthcare providers, and their advocacy organizations came together and produced 73,000+ signatures!
In the next few weeks, the FARA (Friedreich’s Ataxia Research Alliance) team will work to compile the signatures, statements, and photos submitted into one letter/document to present to Reata Pharmaceuticals and the Food and Drug Administration (FDA).
This document will request that Reata Pharmaceuticals a New Drug Application (NDA) on an urgent basis and that FDA 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.
Stay tuned in early February for an electronic copy of the letter!
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