WebMay 16, 2024 · Otsuka calls off multibillion-dollar, CKD licensing deal with Akebia in aftermath of CRL Paul Schloesser Associate Editor Back in 2016, Otsuka and Akebia signed the first... WebMar 30, 2024 · Today, the FDA rejected Cambridge, Massachusetts-based Akebia Therapeutics ’ New Drug Application (NDA) for vadadustat, a therapeutic for anemia due to chronic kidney disease (CKD). In its Complete Response Letter, the FDA stated that it was rejecting the application due to safety concerns.
Chronic Kidney Disease (CKD) Treatment Hypertension Treatment …
WebAnalyzing a sample of your urine can reveal abnormalities that point to chronic kidney failure and help identify the cause of chronic kidney disease. Imaging tests. Your doctor might use ultrasound to assess your kidneys' structure and size. Other imaging tests might be used in some cases. Removing a sample of kidney tissue for testing. WebFeb 25, 2024 · About Alport Syndrome Alport syndrome is a rare, genetic form of CKD caused by mutations in the genes encoding type IV collagen, which is a major structural component of the glomerular basement... simply southern grill and buffet menu
FDA Says No to Vadadustat Approval Due to Safety Concerns
WebAn estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73 m 2. Disease monitoring may take place in primary care as part of a shared care agreement. Accelerated progression of chronic kidney disease (CKD), defined as: A sustained decrease in eGFR of 25% or more within 12 months and a change in CKD category. WebApr 1, 2024 · “We are extremely disappointed to receive a CRL for vadadustat, a therapy that has the potential to help patients with anemia due to CKD,” said John P. Butler, CEO … WebIf your kidneys aren’t working properly, the rest of your body isn’t either. Some of the complications of chronic kidney disease include: Low red blood cell count ( anemia ). Weak and brittle bones. Gout. Metabolic acidosis. This is a chemical imbalance (acid-base) in your blood caused by decrease in kidney function. simply southern gray pullover