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DANMARKS STØRSTE INVESTORSITE MED DEBAT, CHAT OG NYHEDER

Calliditas Says FDA Extends PDUFA Goal Date for Nefecon to Dec. 15

14/9 21:12


  • (PLX AI) – Calliditas says U.S. Food and Drug Administration (FDA) has extended the PDUFA goal date for its New Drug Application (NDA) seeking accelerated approval for Nefecon to December 15, 2021.
  • • In March Calliditas filed for FDA approval using the Accelerated Approval Program, based on the proteinuria endpoint as previously discussed with the Agency, reflecting data from the 200 patients in Part A of the NefIgArd trial
  • • In its review of the NDA, the FDA has requested further analyses of the NeflgArd trial data which the company has provided to the FDA
  • • The Agency has classified these analyses as a major amendment to the NDA