With full approval from the U.S. FDA in hand for Travere Therapeutics Inc.’s Filspari (sparsentan) to slow kidney function decline in adults with primary IgA nephropathy (IgAN) who are at risk of disease progression, eyes turned to future prospects as well as how a revised risk evaluation and mitigation strategies (REMS) program might shake out. During a conference call hosted by Travere, Leerink analyst Joseph Schwartz wanted to know what changes might be made, and if the regulator’s decision might “actually be an entire removal” of the REMS.
Recent research indicates that CDC42 plays a role in the pathogenesis of kidney disorders such as congenital nephrotic syndrome or glomerulosclerosis because it is necessary for the correct function of renal podocyte and tubule.
Recent findings suggest gut microbiota dysbiosis may be behind the inflammation in diabetic nephropathy (DN), the leading cause of end-stage renal disease (ESRD).
Shanghai Micurx Pharmaceutical Co. Ltd. has discovered peptide-drug conjugates consisting of peptide-targeting kidney cells covalently linked to anti-inflammatory or immunomodulating or nephron-protective drugs through linkers reported to be useful for the treatment of acute kidney injury, nephritis, chronic kidney disease, chronic glomerulonephritis, diabetic nephropathy and systemic lupus erythematosus, among others.
Acute kidney injury (AKI) is a common disease with high morbidity that still lacks effective drug treatments. The death of tubular epithelial cells is the principal basis for AKI. This cell death in AKI does not occur by necrosis but by other cell death mechanisms such as pyroptosis, among others. Recent findings have implicated chromodomain Y-like (CDYL) in autosomal dominant polycystic kidney disease, but its role in AKI has not been established.
More than 18 months after announcing plans to spin off its kidney care division as a standalone public company, Baxter International Inc. reached an agreement to sell the business for $3.8 billion to global equity investor Carlyle and Atmas Health instead. The transaction is expected to close in late 2024 or the first quarter of 2025.
The U.S. FDA has granted accelerated approval to Novartis AG’s Fabhalta (iptacopan) for reducing proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. The approval strengthens the company’s renal disease presence as it puts two other IgAN treatments through clinical trials.
Meta Pharmaceuticals Inc. announced that the FDA has granted rare pediatric disease designation to its investigational new drug META-001-PH for the treatment of primary hyperoxaluria (PH), an autosomal recessive metabolic disorder in which oxalate is overproduced and deposited in the body.
An antibody that binds to the latent form of transforming growth factor-β1 (TGF-β1) prevented its release into the extracellular matrix and reduced the progression of fibrosis in the kidney. TGF-β is synthesized and secreted into the extracellular matrix in a latent inactive form associated with the latency peptide.
About four months after varoglutamstat failed in Alzheimer’s disease, Vivoryon Therapeutics NV disclosed data from the Viviad phase IIb study with the same compound in kidney disease that provided cause for hope – and Anne Doering, chief financial officer, said the new data “reinforce our strategic shift.”