FDAapproves pegunigalsidase alfa, an enzyme replacement therapy to treat adults with confirmed Fabrydisease.
Fabry disease is a rare inherited X-linked lysosomal disorder caused by a deficiency of the enzyme alpha-galactosidase A , which leads to the buildup of globotriaosylceramide in blood vessels, kidneys, heart, nerves, and other organs, increasing the risk for kidney failure, myocardial infarction, stroke, and other problems.Evidence for safety, tolerability, and efficacy of Elfabrio stem from a comprehensive clinical program in more than 140 patients with up to 7.5 years of follow up treatment.
It has been studied in both ERT-naïve and ERT-experienced patients.
Before administering Elfabrio, pretreatment with antihistamines, antipyretics, and/or corticosteroids should be considered, the label advises. Patients and caregivers should be informed of the signs and symptoms of hypersensitivity reactions and infusion-associated reactions and instructed to seek medical care immediately if such symptoms occur.
A case of membranoproliferative glomerulonephritis with immune depositions in the kidney was reported during clinical trials. Monitoring serum creatinine and urinary protein-to-creatinine ratio is advised. If glomerulonephritis is suspected, treatment should be stopped until a diagnostic evaluation can be conducted.
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