FDA Grants Fast Track Status to Oral Therapy Candidate Omaveloxolone

FDA Grants Fast Track Status to Oral Therapy Candidate Omaveloxolone

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FDA Grants Fast Track Status to Oral Therapy Candidate Omaveloxolone

The U.S. Food and Drug Administration (FDA) has granted its fast track designation to Reata Pharmaceuticals’ oral candidate omaveloxolone for Friedreich’s ataxia (FA). Fast track status is designed to accelerate the development of investigational therapies that address unmet medical needs in serious or life-threatening conditions. It makes Reata eligible for more frequent meetings with the FDA and discussions about omaveloxolone’s development plan. “We are pleased to receive fast track designation as it highlights the potential of…

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