Amicus’s Galafold (migalastat) Receives FDA Approval for Treating Fabry Disease after 15 yrs

 Amicus’s Galafold (migalastat) Receives FDA Approval for Treating Fabry Disease after 15 yrs

Amicus’s Galafold (migalastat) Receives FDA Approval for Treating Fabry Disease after 15 yrs

Shots: 

• Galafold is a first precision and oral drug (Q2D) for 348 amenable galactosidase alpha gene (GLA) variants to treat Fabry in U.S. 
• The approval was under Subpart H Accelerated Approval pathway based on reduction of KIC GL-3 substrate 
• Approval is based on Ph 3 FACETS study (Study 011) in treatment-naive patients showing efficacy and reducing the amount of disease substrate in kidney,Amicus continues to study Galafold in Ph 4

Click here to read full press release/ article | Ref: Amicusrx| Image:  MDA

Shiwani Sharma

Shiwani Sharma was Senior Editor at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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