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THERANEXUS and BBDF obtain orphan drug designation and Rare Paediatric Disease Designation

 

THERANEXUS and BBDF obtain orphan drug designation (ODD) and Rare Paediatric Disease Designation (RPDD) from the Food And Drug Administration (FDA) for BBDF-101 for Batten disease

 

  • Orphan Drug Designation (ODD) is a status that provides seven years of additional post-approval protection and exemption from filing fees
  • Rare Pediatric Disease Designation (RPDD) qualifies the sponsor at the time of registration for a salable, transferable priority review voucher which can be used to speed up the approval process for another drug candidate

 

Lyon, 11 August 2020 – Theranexus, a biopharmaceutical company innovating in the treatment of neurological diseases, and Beyond Batten Disease Foundation (BBDF) today announced the decision by the Food and Drug Administration (FDA) to award Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) to the drug candidate BBDF-101 for Batten disease, a rare, fatal, genetic disorder of the nervous system for which there is no treatment.

 

Read the press release