GSK's anemia drug "Jesduvroq" approved by USFDA for patients on dialysis


eMediNexus    02 February 2023

GSK drug "Jesduvroq" received approval by the U.S. Food and Drug Administration (USFDA) on Wednesday for anaemia caused by chronic renal disease in individuals who have received at least four months of dialysis.


"Jesduvroq" is the first oral treatment for diseases. The approval comes with a boxed warning for increased thrombotic vascular events, such as mortality, heart attack, stroke, and blood clots in the lungs, legs, or dialysis access site. The warnings and precautions also mentioned the risk of hospitalization for heart failure, a worsening rise in blood pressure, stomach erosions, and gastrointestinal bleeding. The medication is not approved for patients not receiving dialysis, as the safety has not been proven in such patients.


The U.S. FDA has approved this medication as the first HIF-PH inhibitor of its kind. HIF-PH inhibitors are a type of oral medication created to promote the production of red blood cells by stimulating the body′s response at high altitudes, where a lack of oxygen results in an increase in haemoglobin concentration and the number of red blood cells.


The approval was given after FDA′s advisory committee′s recommended the treatment in October for select kidney disease patients. This is GSK′s first approval since the company′s consumer health division, which produced Sensodyne toothpaste and Advil painkillers, was spun off last year.


GSK stated that the "Jesduvroq" wholesale acquisition price has not yet been determined. In order to secure prompt reimbursement and patient access to Jesduvroq, they were submitting the necessary documentation to the Centers for Medicare & Medicaid Services (CMS), as 87% of dialysis patients were beneficiaries of Medicare.


(Source: https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-gsks-anemia-drug-2023-02-01/)

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