Cost regulators for treatments funded on the NHS in England and Wales are backing use of Amgen’s Parsabiv to treat secondary hyperparathyroidism (sHPT), which could give patients routine access to the first new option to treat the disease in more than a decade.
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Amgen’s Parsabiv has now been cleared for use in the US to treat secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on haemodialysis, after it was initially rejected by the US Food and Drug Administration in October last year.
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European regulators have approved Amgen’s Parsabiv for secondary hyperparathyroidism (sHPT), giving patients the potential to access the first new option to treat the disease in more than a decade.
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Ten new medicines have taken a giant leap closer to European Union approval after having won the backing of the Committee for Medicinal Products for Human Use.
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US regulators have turned down Amgen’s request to market Parsabiv for secondary hyperparathyroidism (sHPT).
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