Intellia, Verve run clinical trials abroad amid FDA’s ‘cautious’ approach to gene editing
Intellia Therapeutics announced earlier this month that it would run a mid-stage trial of a CRISPR-based treatment for a rare genetic disease called hereditary angioedema (HAE) entirely outside of the US. The decision came after the FDA asked for more research on reproductive effects if the trial was to include women of child-bearing age.
So far, at least two gene editing companies — Intellia and Verve Therapeutics — have decided to run early- or mid-stage clinical trials outside the US, as FDA takes a more cautious approach than foreign regulators to the nascent field of gene editing.
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