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Reata Announces that The FDA Has Asked The Company to Request a Pre-NDA Meeting for Omaveloxolone for the Treatment of Friedreich’s Ataxia

FARA Co-Founder and President, Ron Bartek and FARA CEO, Jennifer Farmer said, "Thank you to the entire global Friedreich's ataxia community- individuals with FA, family, friends, clinicians, and researchers- who shared their voices as part of the FA Community Petition: Allow Individuals with Friedreich's Ataxia Access to Omaveloxolone which was sent to Reata Pharmaceuticals and the Food and Drug Administration (FDA).

The FDA's request for a Pre- NDA meeting demonstrates the power of the community’s unified voice. Thank you to the FDA for demonstrating flexibility, being open to additional data analysis, and considering the patient voice in the drug development process. We are also grateful to Reata Pharmaceuticals for their steadfast commitment to the omaveloxolone program in FA. FARA looks forward to working with both Reata and the FDA in the next steps of the process and keeping the community informed."

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