FDA not to hold AdCom on Reata's omaveloxolone
US clinical-stage drug developer Reata Pharmaceuticals (Nasdaq: RETA) edged up 2.6% to $25.05 yesterday, when it puzzled investors with the news that the US Food and Drug Administration (FDA) has decided not to hold an advisory committee (AdCom) meeting in connection with its review of the company’s New Drug Application (NDA) for omaveloxolone for the treatment of patients with Friedreich’s ataxia.
“Friedreich’s ataxia is a rare, genetic, debilitating, and degenerative neuromuscular disorder with no approved therapies, and we are committed to our goal of working to secure approval for omaveloxolone for patients living with this severe disease,” said Warren Huff, Reata’s chief executive.
No further explanation was offered by the company.
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