PDUFA approval

Calliditas Therapeutics’ Nefecon Receives FDA Priority Review for IgA Nephropathy

April 29, 2021

The FDA has granted Priority Review to Calliditas Therapeutics’ Nefecon (targeted-release budesonide formulation) for regulating the antibody immunoglobulin (IgA) that can build up in the kidneys and cause a condition known as IgA nephropathy, or Berger’s disease.

The company’s New Drug Application was supported by positive data from two clinical trials that showed the drug to be safe and well-tolerated.

“We look forward to engaging with the agency and work toward an accelerated approval later this year,” said Calliditas’ CEO Renée Aguiar-Lucander.

The FDA has set a PDUFA approval action date of Sept. 15. A confirmatory phase 3 trial on long-term kidney outcomes is fully enrolled and results should be made available in early 2023, the company said.

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