European approval for Amicus' Galafold for Fabry disease
US biotech Amicus Therapeutics (Nasdaq: FOLD) has received approval from the European Commission for Galafold (migalastat) as a treatment for patients diagnosed with Fabry disease and who have an amenable mutation.
Amicus started supplying the market in Germany on Monday and will begin the reimbursement processes with healthcare authorities in each of the major European countries.
The oral small molecule pharmacological chaperone Galafold is the first precision medicine approved for the disease. The broad label includes 269 Fabry-causing mutations which represent 35% to 50% of all patients with the disorder.
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