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Is CRISPR safe? Genome editing gets its first FDA scrutiny

Advisers to the US regulatory agency will examine the safety profile of a CRISPR-based treatment for sickle-cell disease.
  1. Heidi Ledford
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A therapy based on the CRISPR–Cas9 genome-editing system could become the first of its kind to gain approval from the US Food and Drug Administration. But the treatment — designed to alleviate a painful blood condition — must first face intense scrutiny by the agency and its advisers.

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Nature 623, 234-235 (2023)

doi: https://doi.org/10.1038/d41586-023-03317-7

Updates & Corrections

  • Correction 31 October 2023: An earlier version of this article incorrectly stated the location of bluebird bio. It also incorrectly stated the number of clinical trial participants who provided data about vaso-occlusive crises at nine months and the number who had not had a crisis.

  • Correction 07 November 2023: One sentence in an earlier version of this article misspelt Tosin Ola’s surname.

References

  1. Goyal, S. et al. N. Engl. J. Med. 386, 138–147 (2022).

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  2. Brunson, A. et al. Blood 130, 1597–1599 (2017).

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