FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

NICE Gives Nod to Amicus’ Galafold for Fabry Disease

Jan. 11, 2017

The UK’s National Institute for Health and Care Excellence is backing the reimbursement of Amicus’ Galafold to treat Fabry disease in patients 16 and older with an amenable mutation, provided the company discounts the drug’s price.

The recommendation also stipulates that Galafold be reimbursed only when enzyme replacement therapy is the alternative treatment. The drug cost watchdog recommended the therapy based on the likelihood that Galafold could provide greater health benefits than standard treatments, such as enzyme replacement therapy.

In clinical trials, Galafold showed comparable effectiveness to enzyme replacement therapy (ERT), and given its oral route of administration, NICE determined that it could offer a more convenient therapeutic delivery than ERT.

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