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Nefecon, a new drug for primary IgA nephropathy, applies for listing in the United States!

 Last Update: 2021-03-27
 Source: Internet
 Author: User

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The Swedish biopharmaceutical company Calliditas Therapeutics recently announced that it has submitted a new drug application (NDA) for Nefecon (budesonide) to the US Food and Drug Administration (FDA), a new oral formulation that targets down-regulation of IgA1 for the treatment of primary IgA.

Nefecon is a patented oral preparation containing a potent and well-known active substance-budesonide-for targeted release.

As shown in the large Phase 2b trial completed by Calliditas, the combination of dose and optimized release profile is effective for IgAN patients.

NefIgArd Clinical Trial Part A Results

Calliditas is the only company that has obtained positive data in phase 2b and phase 3 randomized, double-blind, placebo-controlled clinical trials of IgAN.

The Nefecon NDA submission is based on the positive data from part A of the key phase 3 study of NefIgArd.

Calliditas has applied for accelerated approval.

Original source: Calliditas Announces Submission of New Drug application to US FDA for Nefecon in Patients with Primary IgA Nephropathy

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