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News from April 27, 2021 // --Reata Pharma is a clinical-stage biopharmaceutical company dedicated to the development of innovative therapies through molecular pathways involving cell metabolism and inflammation regulation for the treatment of serious or life-threatening diseases
.
Recently, the company announced that the US Food and Drug Administration (FDA) has accepted a new drug application (NDA) for bardoxolone methyl (bardoxolone) for the treatment of chronic kidney disease (CKD) caused by Alport syndrome
.
The FDA will review the NDA in accordance with a standard review schedule.
The target date for the Prescription Drug User Fee Act (PDUFA) is February 25, 2022
.
The FDA also informed Reata that it is currently planning to convene an advisory committee meeting to discuss the NDA
.
FDA meeting.
Recently, the company announced that the US Food and Drug Administration (FDA) has accepted a new drug application (NDA) for bardoxolone methyl (bardoxolone) for the treatment of chronic kidney disease (CKD) caused by Alport syndrome
.
The FDA will review the NDA in accordance with a standard review schedule.
The target date for the Prescription Drug User Fee Act (PDUFA) is February 25, 2022
.
The FDA also informed Reata that it is currently planning to convene an advisory committee meeting to discuss the NDA
.
Alport syndrome is a hereditary nephritis, a genetic disease that mainly affects the kidneys , affecting approximately 30,000-60,000 people in the United States.
It is a life-threatening disease and there is no approved treatment
.
If approved, bardoxolone will become the first treatment for Alport syndrome in the US market
.
According to a forecast report released by EvaluatePharma at the beginning of the year by the pharmaceutical market research agency, early sales of bardoxolone are expected to be very small, but it will quickly reach a heavyweight (1 billion US dollars) status in 2024 , with estimated sales of 1.
12 billion US dollars, 2026 It will further accelerate to 2.
5 billion US dollars in the year
.
If genetics is approved, bardoxolone will become the first therapy for Alport syndrome in the U.It is a life-threatening disease and there is no approved treatment
.
If approved, bardoxolone will become the first treatment for Alport syndrome in the US market
.
According to a forecast report released by EvaluatePharma at the beginning of the year by the pharmaceutical market research agency, early sales of bardoxolone are expected to be very small, but it will quickly reach a heavyweight (1 billion US dollars) status in 2024 , with estimated sales of 1.
12 billion US dollars, 2026 It will further accelerate to 2.
5 billion US dollars in the year
.
S.
market , and it will quickly reach a heavyweight ($1 billion) status in 2024.
It will further accelerate to $2.
5 billion in 2026.
Reata Warren Huff, President and CEO, said: "We are very pleased that FDA accepted bardoxolone NDA, and look forward to continue the review process with the FDA cooperation
.
Alport syndrome is one of the fastest progress of CKD type of patients and their families It is a truly devastating disease
.
If approved, bardoxolone may become the first drug to treat Alport syndrome and slow the progression of kidney disease in patients
.
"
FDA.
Alport syndrome is one of the fastest progress of CKD type of patients and their families It is a truly devastating disease
.
If approved, bardoxolone may become the first drug to treat Alport syndrome and slow the progression of kidney disease in patients
.
"
Alport syndrome-hereditary nephritis (picture source: epainassist.
com)
com)
The NDA is based on the efficacy and safety data from the CARDINAL Phase 3 clinical trial
.
This is a double-blind, placebo-controlled, randomized trial that recruited 157 patients with CKD caused by Alport syndrome in approximately 50 study sites in the United States, Europe, Japan, and Australia
.
In the trial, patients were randomly assigned at a 1:1 ratio and received oral bardoxolone or placebo once a day
.
The primary endpoint for the second year of the study was the change in estimated glomerular filtration rate (eGFR) from baseline after 100 weeks of treatment
.
The key secondary endpoint is the change in eGFR from baseline at week 104 (4 weeks after the last dose in the second year of treatment)
.
Clinical Trials.
This is a double-blind, placebo-controlled, randomized trial that recruited 157 patients with CKD caused by Alport syndrome in approximately 50 study sites in the United States, Europe, Japan, and Australia
.
In the trial, patients were randomly assigned at a 1:1 ratio and received oral bardoxolone or placebo once a day
.
The primary endpoint for the second year of the study was the change in estimated glomerular filtration rate (eGFR) from baseline after 100 weeks of treatment
.
The key secondary endpoint is the change in eGFR from baseline at week 104 (4 weeks after the last dose in the second year of treatment)
.
The results showed that in the 100th and 104th weeks, the renal function of patients in the bardoxolone treatment group was statistically significantly improved compared with the placebo group
by eGFR measurement .
In this study, bardoxolone was well tolerated and its safety profile was similar to that observed in previous trials
.
The reported adverse events (AE) were generally mild to moderate.
Compared with placebo-treated patients, the most common adverse events in bardoxolone-treated patients were muscle cramps and elevated transaminases
.
Compared with the placebo group, the renal function of patients in the bardoxolone treatment group was statistically significantly improved by eGFR measurement .
In this study, bardoxolone was well tolerated and its safety profile was similar to that observed in previous trials
.
The reported adverse events (AE) were generally mild to moderate.
Compared with placebo-treated patients, the most common adverse events in bardoxolone-treated patients were muscle cramps and elevated transaminases
.
.
Molecular structure of bardoxolone methyl (picture source: adooq.
com)
com)
Alport syndrome is a rare hereditary CKD caused by mutations in the gene encoding type IV collagen
.
Type IV collagen is the main structural component of the basement membrane of the kidney glomerulus
.
Alport syndrome affects children and adults.
The patient’s kidneys gradually lose the ability to filter waste from the blood.
This may lead to end-stage kidney disease (ESKD), requiring chronic dialysis treatment or kidney transplantation
.
Among patients with the most severe disease types, the dialysis rate is about 50% at 25 years old, about 90% at 40 years old, and about 100% at 60 years old
.
According to the Alport Syndrome Foundation (Alport Syndrome Foundation), Alport syndrome affects approximately 30,000-60,000 people in the United States.
There is currently no drug approved for the treatment of CKD caused by Alport syndrome
.
Genetic.
Type IV collagen is the main structural component of the basement membrane of the kidney glomerulus
.
Alport syndrome affects children and adults.
The patient’s kidneys gradually lose the ability to filter waste from the blood.
This may lead to end-stage kidney disease (ESKD), requiring chronic dialysis treatment or kidney transplantation
.
Among patients with the most severe disease types, the dialysis rate is about 50% at 25 years old, about 90% at 40 years old, and about 100% at 60 years old
.
According to the Alport Syndrome Foundation (Alport Syndrome Foundation), Alport syndrome affects approximately 30,000-60,000 people in the United States.
There is currently no drug approved for the treatment of CKD caused by Alport syndrome
.
Bardoxolone is an investigational, once-daily, oral Nrf2 activator
.
Nrf2 is a transcription factor that can induce multiple molecular pathways that restore mitochondrial function, reduce oxidative stress and inhibit pro-inflammatory signals, and promote the regression of inflammation
.
In the United States, bardoxolone was granted Orphan Drug Designation (ODD) for the treatment of Alport syndrome and autosomal dominant polycystic kidney disease (ADPKD); in the European Union, bardoxolone was also granted the ODD for the treatment of Alport syndrome
.
.
Nrf2 is a transcription factor that can induce multiple molecular pathways that restore mitochondrial function, reduce oxidative stress and inhibit pro-inflammatory signals, and promote the regression of inflammation
.
In the United States, bardoxolone was granted Orphan Drug Designation (ODD) for the treatment of Alport syndrome and autosomal dominant polycystic kidney disease (ADPKD); in the European Union, bardoxolone was also granted the ODD for the treatment of Alport syndrome
.
In addition to the CARDINAL Phase 3 study, bardoxolone is currently evaluating the treatment of ADPKD patients in the FALCON Phase 3 study and CKD patients who are at risk of rapid progress in the MERLIN Phase 2 study
.
In addition, Kyowa Kirin has obtained a bardoxolone license from Reata and is currently evaluating the treatment of diabetic nephropathy (DKD) in the AYAME Phase 3 study
.
Up to now, the Phase 2 study of bardoxolone in the treatment of CKD patients caused by ADPKD, IgA nephropathy, focal segmental glomerulosclerosis, and type 1 diabetes has achieved positive results
.
()
Diabetes Diabetes.
In addition, Kyowa Kirin has obtained a bardoxolone license from Reata and is currently evaluating the treatment of diabetic nephropathy (DKD) in the AYAME Phase 3 study
.
Up to now, the Phase 2 study of bardoxolone in the treatment of CKD patients caused by ADPKD, IgA nephropathy, focal segmental glomerulosclerosis, and type 1 diabetes has achieved positive results
.
()
Original source: Reata Announces FDA Accepted for Filing the NDA for Bardoxolone for the Treatment of Patients With Chronic Kidney Disease Caused by Alport Syndrome
FDA 
