Difelikefalin for pruritus associated with chronic kidney disease
Difelikefalin is a potent kappa opioid receptor agonist that is an itch and inflammation suppressant. Difelikefalin intravenous injection acts as an itch and inflammation suppressant without the undesirable side-effects typical of a centrally-acting opioid medicine such as hallucinations or opioid addiction. If licensed, difelikefalin will offer an additional treatment option for adult haemodialysis patients with moderate to severe CKD-aP who currently have few effective therapies available.
Human acellular vessel for vascular access for haemodialysis in end-stage renal disease
The Human acellular vessel (HAV) is in clinical development to provide vascular access for haemodialysis patients with end-stage renal disease (ESRD). ESRD is a long-term irreversible condition where the kidneys do not work as well as they should as a result of chronic kidney disease. There is no cure for kidney failure and patients with this condition requires haemodialysis or a renal transplant for survival. Haemodialysis works by taking blood from the body and cleaning it through a machine to remove the toxins. Blood is filtered before being returned to the body. Vascular access is a way to reach the blood during haemodialysis.
Lumasiran for primary hyperoxaluria type I
Lumasiran, which is administered as a subcutaneous injection, is designed to reduce the levels of an enzyme called glycolate oxidase produced by the liver. Oxalate production is therefore inhibited. By reducing oxalate production, lumasiran has the potential to prevent the actual disease process that develops in PH1. If licensed, lumasiran may provide the first pharmacological treatment option for patients with PH1 who do not have any approved treatment.
Fedovapagon for nocturia in men with benign prostatic hyperplasia
Fedovapagon works directly in the collecting ducts of the kidney by binding to, and activating receptors that causes the kidneys to reabsorb water from urine as it passes towards the bladder. If fedovapagon is administered before going to bed the result is less urine produced overnight. Therefore, if licensed, fedovapagon would be the first medicinal product specifically for the treatment of nocturia in men with enlarged prostates.
Roxadustat for Renal Anaemia in Chronic Kidney Disease
Roxadustat is a product in development that can be taken orally as a tablet. It has the potential to stimulate the growth of red blood cells by increasing the body’s own production of EPO in patients with CKD who may be on dialysis or pre‐dialysis. If approved for the treatment of anaemia in this population, roxadustat will provide an alternative treatment option that offers a likely reduction in the need for supplemental iron as an advantage.
Fexapotide Triflutate for Benign Prostatic Hyperplasia
Benign prostatic hyperplasia (BPH) is a medical term that is used to describe enlargement of the prostate gland. It is not a cancer and is usually not a serious threat to health if well-treated. Most males aged 50 years and above develop BPH.
Nefecon (targeted-release budesonide formulation) for IgA Nephropathy (Berger’s disease)
Budesonide is a steroid drug which reduces inflammation. Nefecon is a new oral formulation of budesonide that is designed to specifically deliver the drug to a place in the intestine where most of the immune cells producing IgA are located. This has the potential advantage of targeting the underlying process that causes IgAN with significantly fewer side effects when compared to the generally used systemic steroids such as prednisone, (which is delivered throughout the whole body). If licenced, Nefecon has the potential to become the first disease-specific treatment for IgAN.
PERiPLEX for the detection of acute infection in peritoneal dialysis
PERiPLEX® is a point-of-care test for the detection of markers of infection (peritonitis) in people undergoing peritoneal dialysis for end stage renal disease. It is designed to be suitable for self-testing. The assay has been developed by Mologic Ltd. and may enable people to test for the presence of acute infection in their own home.
Plazomicin for complicated urinary tract infection
Serious infections caused by Gram-negative bacteria are becoming increasingly resistant to commonly prescribed antibiotics and are a serious global concern. If licensed, plazomicin will offer a treatment option for those patients who have a complicated urinary tract infection or acute pyelonephritis caused by multi-drug resistant Gram-negative bacteria, a group who currently have few effective and …