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Informational Webinar on Omav Headlines

Understanding the Latest
Headlines on Omav

Review of Data & Developments

Informational Webinar - August 30, 2022

Reata Pharmaceuticals recently completed a mid-cycle communication meeting with the Food and Drug Administration (FDA) where feedback arising from the current review of the New Drug Application (NDA) for Omaveloxolone for the treatment of Friedreich’s ataxia was provided to Reata. At this meeting, the FDA agreed that Reata could submit updated supportive data to the existing NDA. With this data now submitted, the FDA has advised that they will require an extension to appropriately consider the updated application. The review is now due to conclude on February 28, 2023.

FARA CEO, Jen Farmer and study Principal Investigator, Dr. David Lynch hosted an informational webinar on these new developments, covering these topics:
  • The significance of the three new datasets submitted by Reata to FDA
  • How FACOMS natural history study data played a role in this submission
  • Why the new data was submitted now and why the FDA requires an extension on their review
  • FARA's response to these developments

View the Webinar Recording

Click the links below to read the most recent press releases from Reata Pharmaceuticals.

 
 

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