PDUFA goal date extension for Nefecon NDA in the U.S.

pdufa goal date extension for nefecon nda in the u s

Sumary of PDUFA goal date extension for Nefecon NDA in the U.S.:

  • The FDA has therefore extended the PDUFA goal date to December 15, 2021.”Our NDA for Nefecon is the first time that the FDA is considering an approval on the basis of proteinuria as a surrogate endpoint for accelerated approval in IgA nephropathy, requiring an in-depth review process.
  • Story continuesAbout Calliditas Calliditas Therapeutics is a biopharma company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs.
  • Calliditas’ lead product candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of adults with the autoimmune renal disease primary IgA nephropathy (IgAN), for which there is a high unmet medical need and there are no approved treatments.
  • Calliditas is also planning to start clinical trials with NOX inhibitors in primary biliary cholangitis and head and neck cancer.
  • Forward-looking statementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding Calliditas’ strategy, business plans and focus.

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