Trinucleotide repeat expansion

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

Retrieved on: 
Wednesday, May 19, 2021
Branches of biology, Frataxin, Proteins, Trinucleotide repeat expansion, Ataxin, Omaveloxolone, Trinucleotide repeat disorder, NFE2L2, Friedreich's ataxia

The Division suggested that the Company withdraw the current meeting request for a Type C meeting and instead request a pre-NDA meeting, which the Division will grant upon receipt.

Key Points: 
  • The Division suggested that the Company withdraw the current meeting request for a Type C meeting and instead request a pre-NDA meeting, which the Division will grant upon receipt.
  • FA is typically caused by a trinucleotide repeat expansion in the first intron of the frataxin gene, which encodes the mitochondrial protein frataxin.
  • The FDA has granted Orphan Drug designation to omaveloxolone for the treatment of Friedreich\xe2\x80\x99s ataxia.
  • Reata possesses exclusive, worldwide rights to develop, manufacture, and commercialize omaveloxolone, and our other next-generation Nrf2 activators.