Amicus Therapeutics’ Galafold (migalastat) Receives FDA Approval for Fabry Disease in Adult Patients

 Amicus Therapeutics’ Galafold (migalastat) Receives FDA Approval for Fabry Disease in Adult Patients

Amicus Therapeutics’ Galafold (migalastat) Receives FDA Approval for Fabry Disease in Adult Patients

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

Click here to read full press release/ article | Ref: Amicus Therapeutics | Image: Reuters