EC approves Amicus' Galafold

The European Commission approved an MAA for Galafold migalastat from Amicus Therapeutics Inc. (NASDAQ:FOLD) to treat Fabry's disease. Amicus said the label covers 35-50% of Fabry's patients with any of 269 disease-causing mutations determined to be amenable to Galafold therapy using the Galafold Amenability Assay.

Amicus has launched the drug in Germany. The company said it would price the small molecule that enhances alpha galactosidase A activity on par with enzyme replacement therapies for Fabry's disease, but did not give a specific price. ...