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Kidney (Image source: thehealthsite.
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com)
News on March 15, 2021 /bioon.
com" target="_blank">/ --Swedish biopharmaceutical company Calliditas Therapeutics recently announced that it has submitted a new drug application (NDA) for Nefecon (budesonide) to the U.
S.
Food and Drug Administration ( bioon.
com/fda/" target="_blank">FDA ), which is a new oral formulation that targets downregulation of IgA1 therapeutics.
IgA nephropathy (IgAN).
The company is seeking to apply for accelerated approval through the 505(b)(2) route.
If approved, Nefecon will be the first therapy specifically designed and approved for the treatment of IgAN.
bioon.com" target="_blank">/ --Swedish biopharmaceutical company Calliditas Therapeutics recently announced that it has submitted a new drug application (NDA) for Nefecon (budesonide) to the U.
S.
Food and Drug Administration ( bioon.
com/fda/" target="_blank">FDA ), which is a new oral formulation that targets downregulation of IgA1 therapeutics.
IgA nephropathy (IgAN).
The company is seeking to apply for accelerated approval through the 505(b)(2) route.
If approved, Nefecon will be the first therapy specifically designed and approved for the treatment of IgAN.
com" target="_blank">bioon.
com/fda/" target="_blank">FDA Nefecon will be the first therapy specifically designed and approved for the treatment of IgAN.
Renée Aguiar Lucander, CEO of Calliditas, said: "This is a key milestone in the company's development.
We look forward to working with this agency.
This is the first time a drug specifically targeting IgAN has been submitted to the bioon.
com/fda/" target="_blank">FDA for approval.
I believe we provide A very reliable data package, based on the successful results of our key Phase 3 trials and Phase 2b trials, which met both primary and key secondary endpoints.
Calliditas has long been committed to developing a precision-based And disease-modified IgAN treatment methods.
This method focuses on the origin of the disease and hopes to help thousands of patients, so today is indeed a special day.
"
bioon. We look forward to working with this agency.
This is the first time a drug specifically targeting IgAN has been submitted to the bioon.
com/fda/" target="_blank">FDA for approval.
I believe we provide A very reliable data package, based on the successful results of our key Phase 3 trials and Phase 2b trials, which met both primary and key secondary endpoints.
Calliditas has long been committed to developing a precision-based And disease-modified IgAN treatment methods.
This method focuses on the origin of the disease and hopes to help thousands of patients, so today is indeed a special day.
"
com/fda/" target="_blank">FDA
jpg" target="_blank">
jpg" target="_blank">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 drugs to the Peyer's patch in the lower small intestine where the disease originated.
Nefecon is derived from TARGIT technology, which allows substances to pass through the stomach and intestines without being absorbed, and can only be released in pulses when they reach the lower part of the small intestine.
According to the main pathogenesis model, the preparation is designed to deliver drugs to the Peyer's patch in the lower small intestine where the disease originated.
Nefecon is derived from TARGIT technology, which allows substances to pass through the stomach and intestines without being absorbed, and can only be released in pulses when they reach the lower part of the small intestine.
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.
This means that high-concentration drugs can be applied locally where needed, but systemic exposure and side effects are very limited.
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.
This means that high-concentration drugs can be applied locally where needed, but systemic exposure and side effects are very limited.
jpg" target="_blank">
jpg" target="_blank">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 bioon.
com/course_video/lin-chuang-shi-yan-de-feng-xian-jian-kong239833.
html">clinical trials of IgAN .
bioon. com/course_video/lin-chuang-shi-yan-de-feng-xian-jian-kong239833.
html">clinical trials of IgAN .
com/course_video/lin-chuang-shi-yan-de-feng-xian-jian-kong239833.
html">Clinical Trials
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 to evaluate the efficacy and safety of Nefecon and placebo in 200 adult IgAN patients.
As mentioned earlier, compared with placebo, the study reached the primary endpoint of reducing proteinuria and showed that eGFR was stable at 9 months.
The NefIgArd test also showed that Nefecon was generally well tolerated and its safety was in line with the phase 2b results.
The submitted information also includes clinical data from the NEFIGAN Phase 2 trial, which also reached the primary and secondary endpoints of the NefIgArd study.
This is a randomized, double-blind, placebo-controlled, international multicenter study to evaluate the efficacy and safety of Nefecon and placebo in 200 adult IgAN patients.
As mentioned earlier, compared with placebo, the study reached the primary endpoint of reducing proteinuria and showed that eGFR was stable at 9 months.
The NefIgArd test also showed that Nefecon was generally well tolerated and its safety was in line with the phase 2b results.
The submitted information also includes clinical data from the NEFIGAN Phase 2 trial, which also reached the primary and secondary endpoints of the NefIgArd study.
Calliditas has applied for accelerated approval.
Accelerated approval is a new drug approval channel of the US bioon.
com/fda/" target="_blank">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 end point of the key phase 3 trial NefIgArd is the reduction of proteinuria compared to placebo, which is 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.
stand by.
A confirmatory study designed to provide long-term kidney benefit data has been fully enrolled and is expected to be announced in early 2023.
()
bioon. Accelerated approval is a new drug approval channel of the US bioon.
com/fda/" target="_blank">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 end point of the key phase 3 trial NefIgArd is the reduction of proteinuria compared to placebo, which is 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.
stand by.
A confirmatory study designed to provide long-term kidney benefit data has been fully enrolled and is expected to be announced in early 2023.
()
com/fda/" target="_blank">FDA ()
Original source: Calliditas Announces Submission of New Drug app lication to US bioon.
com/fda/" target="_blank">FDA for Nefecon in Patients with Primary IgA Nephropathy
app bioon. com/fda/" target="_blank">FDA for Nefecon in Patients with Primary IgA Nephropathy
com/fda/" target="_blank">FDA
