Shots:

• The approval is based on P-III FACET or Study 011 results assessing Galafold (150mg) in patient with Fabry Disease- evaluating its safety and efficacy
• The FACET or Study 011 resulted in reduction of substrate (KIC GL-3) accumulation in the kidney capillaries
• Galafold (migalastat) 123mg is a novel PO dosage form of alpha Galactosidase A used for Fabry Disease in adults and is approved in the US- EU- Australia- Canada- Israel- Japan- South Korea & Switzerland

Ref: Amicus Therapeutics | Image: Reuters