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FDA Roundup: Nephrology Device And Drug Approvals, Warnings – Renal And Urology News – Renal.PlatoHealth.ai

The US Food and Drug Administration (FDA) issued new drug and device approvals for patients with chronic kidney disease, including those on dialysis, during 2023 to Winter 2024. Here are some highlights:

Disclaimer: Please see approved drug labels, warning letters, and complete device information before making clinical decisions.

FDA Device and Drug Approvals

Hemodiafiltration

In February 2024,1 the US Food and Drug Administration (FDA) issued 510(k) clearance for Fresenius Medical Care’s 5008X Hemodialysis System2 –- the first high-volume hemodiafiltration therapy in the US. Following clinical evaluations and user-studies, the 5008X Hemodialysis System should be commercially available in 2025.

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Pediatric AKI Device

In February 2024, the FDA granted Humanitarian Device Exemption Approval to SeaStar Medical’s selective cytopheretic device for children who have acute kidney injury (AKI) due to sepsis or a septic condition requiring kidney replacement therapy (KRT). The immunomodulation device targets proinflammatory neutrophils and monocytes to reduce hyperfiltration. Pediatric patients must weigh at least 10 kilograms (approximately 22 pounds).20 The exemption approval only requires the manufacturer to demonstrate that the device has probable benefit without significant risk. In a study, the device reduced the mortality rate.

Renal Denervation

In November 2023, the FDA granted premarket approval to Medtronic’s Symplicity Spyral Multi-Electrode Renal Denervation Catheter and Symplicity G3 RF Generator. These devices are indicated to reduce blood pressure as an adjunctive treatment in patients with uncontrolled hypertension.3-4

Tarpeyo® (budesonide): IgA nephropathy

In December 2023, the FDA granted full approval to targeted-release budesonide to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy who are at risk for disease progression.5-6

Medication Class: Corticosteroid

Dosing: 16 mg administered orally once in the morning before a meal

Interactions: Strong CYP3A4 inhibitors; grapefruit juice

Special Populations:

Pregnancy: May cause maternal and fetal harm.

Lactation: May cause harm to breastfed infants.

Pediatric use: Safety and effectiveness have not been established.

Geriatric use: Dose cautiously.

Hepatic impairment: Avoid in patients with severe hepatic impairment. Monitor for hypercorticism in patients with moderate hepatic impairment.

Rivfloza™ (nedosiran): Primary hyperoxaluria type 1

In October 2023, the FDA approved nedosiran to lower urinary oxalate levels in children 9 years of age and older and adults with primary hyperoxaluria type 1 and an estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73m2.7-8

Medication Class: LDHA-directed small interfering RNA

Dosing: Subcutaneously once monthly. Adults and adolescents 12 years and older weighing 50 kg or more: 160 mg; weighing less than 50 kg: 128 mg. Children aged 9 to 11 years weighing 50 kg or more: 160 mg; weighing less than 50 kg: 3.3 mg/kg.

Special Populations:

Pregnancy: Safety has not been established.

Lactation: Risks unknown.

Pediatric use: Safety and effectiveness have not been established in children younger than 9 years.

Hepatic impairment: Safety has not been established in patients with moderate to severe hepatic impairment.

Renal impairment: Safety has not been established in patients with an eGFR less than 30 mL/min/1.73m2.

Jardiance® (empagliflozin): Chronic kidney disease

In September 2023, the FDA approved empagliflozin for adults with chronic kidney disease at risk of progression to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization.9-10

Medication Class: Sodium-glucose co-transporter 2 (SGLT2) inhibitor

Dosing: 10 mg orally once daily in the morning

Interactions: Diuretics; insulin or insulin secretagogues; lithium; urine glucose test; 1,5-anhydroglucitol assay

Special Populations:

Pregnancy: May cause maternal and fetal harm.

Lactation: May cause harm to breastfed infants.

Pediatric use: Safety and effectiveness have not been established in children 10 years and younger.

Geriatric use: Greater risk of adverse reactions related to volume depletion and reduced renal function.

Renal impairment: Not recommended when eGFR is less than 30 mL/min/1.73 m2.

Xphozah® (tenapanor): Hyperphosphatemia

In October 2023, the FDA approved tenapanor to reduce serum phosphorus in adults with chronic kidney disease on dialysis as add-on therapy for those with an inadequate response to phosphate binders or intolerance.11-12

Medication Class: Sodium hydrogen exchanger 3 (NHE3) inhibitor

Dosing: 30 mg orally twice daily before the morning and evening meals

Interactions: OATP2B1 substrates; sodium polystyrene sulfonate

Special Populations:

Pregnancy: Potential risks unknown.

Pediatric use: Safety and effectiveness have not been established.

Geriatric use: Potential risks unknown.

Defencath (taurolidine and heparin): Dialysis catheter lock solution

In November 2023, the FDA approved taurolidine and heparin catheter lock solution to reduce catheter-related bloodstream infections in adults with kidney failure receiving chronic hemodialysis through a central venous catheter.13

Medication Class: Thiadiazinane antimicrobial plus an anticoagulant

Dosing: Use 3 mL or 5 mL single-dose vial to instill solution into each catheter lumen at the conclusion of each hemodialysis session.

Special Populations:

Pediatric use: Safety and effectiveness have not been established.

Filspariᵀᴹ (sparsentan): IgA nephropathy

In February 2023, the FDA approved sparsentan, an endothelin and angiotensin II receptor antagonist, to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression (ie, a urine protein-to-creatinine ratio or UPCR of 1.5 g/g or greater).14-15

Medication Class: Endothelin and angiotensin II receptor antagonist

Boxed Warning: Hepatotoxicity and embryo-fetal toxicity

Dosing: 200 mg orally once daily to start

Interactions: Renin-angiotensin system inhibitors; endothelin receptor antagonists; aliskiren; strong and moderate CYP3A inhibitors; strong CYP3A inducers; antacids; acid reducing agents; nonsteroidal anti-inflammatory drugs; CYP2B6, 2C9, and 2C19 substrates; P-glycoprotein and BCRP substrates; agents increasing serum potassium

Special Populations:

Pregnancy: Avoid use. Can cause fetal harm, including birth defects and fetal death.

Lactation: May cause harm to breastfed infants.

Pediatric use: Safety and effectiveness have not been established.

Hepatic impairment: Avoid use. Risk of serious liver injury

Jesduvroq tablets (daprodustat): Anemia of chronic kidney disease during dialysis

In February 2023, the FDA approved oral daprodustat for anemia caused by chronic kidney disease for adults on dialysis.16-17

Medication Class: Hypoxia-inducible factor prolyl hydroxylase inhibitor

Boxed Warning: Increased risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access

Dosing: Orally once daily. Starting dose differs depending on whether or not the patient was receiving an erythropoiesis-stimulating agent, the current hemoglobin level, and hepatic impairment.

Interactions: Moderate or strong CYP2C8 inhibitors; CYP2C8 inducers

Special Populations:

Pregnancy: Risks unknown.

Lactation: May cause harm to breastfed infants.

Pediatric use: Safety and effectiveness have not been established.

Hepatic impairment: Reduce the starting dose if moderate hepatic impairment. Avoid in patients with severe hepatic impairment.

FDA Warnings