NICE issues draft guidance backing Galafold for Fabry disease
USA-based are and orphan disease focussed biotech Amicus Therapeutics (Nasdaq: FOLD) says that the National Institute for Health and Care Excellence (NICE) has issued draft ‘Highly Specialized Technologies’ guidance recommending its Galafold (migalastat) for the treatment of Fabry disease.
The draft guidance from the medicines cost-effectiveness watchdog for England and Wales recommends migalastat only when the company provides it with the confidential discount agreed in the patient access scheme and adds to current approved indications.
With the discount, migalastat provides value for money based on the price of enzyme replacement therapy (ERT), which is the current standard treatment for Fabry disease, the company asserted.
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