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Calliditas Therapeutics recently announced that the US Food and Drug Administration (FDA) has extended the Nefecon (budesonide) New Drug Application (NDA) "Prescription Drug User Fee Act" (PDUFA) target date by 3 months to December 15, 2021 Day
.
In the European Union, Nefecon's Marketing Authorization Application (MAA) is undergoing accelerated evaluation by the European Medicines Agency (EMA)
Nefecon is a new oral preparation of budesonide.
The drug is an IgA1 down-regulating agent that treats primary IgA nephropathy (IgAN) by targeted down-regulation of IgA1
.
If approved, Nefecon will become the first therapy specifically designed and approved for the treatment of IgAN, with disease correction potential
In March 2021, Calliditas submitted an NDA through the accelerated approval program based on the proteinuria endpoint previously discussed with the FDA to seek accelerated approval of Nefecon by the FDA, which reflects the data of the 200 patients in Part A of the NeflgArd trial
.
In April 2021, the FDA accepted the NDA and conducted a priority review, and at the same time designated the PDUFA target date as September 15, 2021
In the review of the NDA, the FDA requested further analysis of the NeflgArd test data provided by Calliditas to the FDA
.
The agency has classified these analyses as major revisions to the NDA
Nefecon: 2-step targeted release technology
Nefecon is a patented oral preparation containing a potent and well-known active substance-budesonide-for targeted release
.
According to the main pathogenesis model, the preparation is designed to deliver the drug to the Peyer's patch in the lower small intestine where the disease originated
As shown in the large Phase 2b trial completed by Calliditas, the combination of dose and optimized release profile is effective for IgAN patients
.
In addition to effective local effects, another advantage of using this active substance is its low bioavailability, that is, approximately 90% of the active substance is inactivated in the liver before reaching the systemic circulation
NefIgArd Clinical Trial Part A Results
Calliditas is the first company to obtain positive data in phase 2b and phase 3 randomized, double-blind, placebo-controlled clinical trials of IgAN
.
Both trials reached the primary and key secondary endpoints
The Nefecon NDA submission is based on the positive data from part A of the key phase 3 study of NefIgArd
.
This is a randomized, double-blind, placebo-controlled, international multicenter study designed to evaluate the efficacy and safety of Nefecon and placebo in 200 adult IgAN patients
When submitting the NDA, Calliditas applied for accelerated approval
.
Accelerated approval is a new drug approval channel of the US FDA, allowing drugs that have the potential to solve the unmet medical needs of major diseases to be approved based on a surrogate endpoint
.
The surrogate endpoint of the key phase 3 trial NefIgArd is the reduction of proteinuria compared to placebo, which was based on the statistical framework of clinical research meta-analysis published by Thompson A et al.
in 2019 for interventions in IgAN patients in clinical studies.
Support
.
A confirmatory study designed to provide long-term kidney benefit data has been fully enrolled and is expected to be announced in early 2023
.
Note: The original text has been deleted
Original source: PDUFA goal date extension for Nefecon NDA in the US
