Dive Brief:
- Amicus Therapeutics on Friday won an accelerated U.S. approval of its Fabry disease drug Galafold, giving patients with the rare genetic disorder a new treatment option for the first time in over a decade.
- The Food and Drug Administration’s OK comes about one year after the agency dropped a requirement for further study of the drug, reversing a 2016 decision that would have substantially delayed when Amicus could have submitted Galafold for approval.
- In an interview, company CEO John Crowley pointed to passage of the 21st Century Cures Act and a re-engagement with regulators as key turning points in getting Galafold back on track in the U.S. Critics, however, question whether the FDA’s acceptance of Galafold’s application pushes regulatory flexibility too far.
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