The rollout follows the final publication of reimbursement guidelines by the Highly Specialized Technologies Evaluation Committee (EC) of the National Institute for Health and Care Excellence (NICE).
The finalization of drug costing and reimbursement structure in the United Kingdom is an important milestone for Amicus, as it continues to proceed with its efforts to launch the drug in the different EU member countries.
The drug is already approved in the European region under the brand name Galafold, and is yet to secure approval by the Food And Drug Administration (FDA) for marketing in the U.S., which represents around one-quarter of the global Fabry market.
(See also, Amicus Posts Positive Update for Migalastat.) Fabry disease is caused by an abnormal buildup of a fatty material called globotriaosylceramide in the blood vessel walls, which is a result of an inherited deficiency of the enzyme called alpha galactosidase A.
This enzyme is responsible for breaking down the globotriaosylceramide which helps in preventing the buildup.