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- A panel of advisers to the U.S. health regulator said on Tuesday Vertex Pharmaceuticals and CRISPR Therapeutics could assess potential safety risks of their sickle cell disease gene therapy after approval.
The inherited red-blood-cell disorder causes the cells to become sickle-shaped due to abnormal levels of hemoglobin in the body. A vaso-occlusive crisis occurs when sickled red blood cells block blood flow to the point that tissues become deprived of oxygen and causes pain. Staff reviewers to the U.S. Food and Drug Administration said the new type of technology raised concerns about the"off target", or unintended genomic alterations that can potentially cause other side effects, but did not raise any concerns about the therapy's efficacy.
"With regards to off target analysis we want to be careful to not let the perfect be the enemy of the good," said Dr. Scot Wolfe, professor at the department of molecular, cell and cancer biology at UMass Chan Medical School.
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