September 17, 2021
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FDA extends PDUFA date for drug to treat IgA nephropathy

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The FDA has extended its Prescription Drug User Fee Act date to Dec. 15 for Nefecon, a drug to treat patients diagnosed with IgA nephropathy, Calliditas Therapeutics AB said in a press release.

"Our [new drug application (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 (IgAN), requiring an in-depth review process,” Renée Aguiar-Lucander, CEO of Calliditas Therapeutics AB, said. “We will continue to cooperate closely with the FDA as they complete the review of our NDA,"

Nefecon is the lead product candidate for Calliditas, based in Stockholm, Sweden. The drug is an oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of adults with IgAN, according to the release.

The company had filed the NDA in March using the FDA’s 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,” the company said. The FDA “has requested further analyses of the NeflgArd trial data which the company has provided to the FDA,” according to the release. “The Agency has classified these analyses as a major amendment to the NDA. The amendment mainly provides additional eGFR and other related analyses as further support of the proteinuria data provided in the NDA submission.”

Reference:

Calliditas Therapeutics. PDUFA goad date extension for Nefecon NDA in the U.S. www.calliditas.se/en/pdufa-goal-date-extension-for-nefecon-nda-in-the-u-s-3809/ Published Sept. 14, 2021. Accessed Sept. 17, 2021.