Once stiff-armed at the FDA, new management offers Amicus a warm embrace for Galafold -- priced at $315,000
It turns out the FDA wasn’t done Friday with the historic approval for Alnylam’s world’s-first RNAi drug. After the market close, Amicus Therapeutics $FOLD revealed that the agency had also come through with an OK for Galafold (migalastat), a controversial new med that had initially been firmly rejected by the agency.
On second glance, which came with an accelerated priority review and some red-carpet treatment at the agency, the FDA determined that Galafold had everything they were looking for in a drug for Fabry disease and an amenable galactosidase alpha gene variant based on in vitro assay data.
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