The Food and Drug Administration has cleared Intellia Therapeutics to start human testing in the U.S. of an experimental CRISPR medicine for a rare swelling disorder, a sign the agency could be getting more comfortable with medicines that edit genes inside the body.
Intellia on Thursday said the FDA will allow it to begin dosing U.S. patients with a drug called NTLA-2002 that the biotechnology company is developing for hereditary angioedema. Intellia has been studying the medicine in an early-stage study that it has so far conducted in the Netherlands, U.K., and New Zealand. With the FDA clearance, Intellia can enroll U.S. patients in a Phase 2 portion of the trial.
