Advisers to the Food and Drug Administration meet Tuesday to review the first treatment of human disease using the gene-editing technique CRISPR. The agency has a December deadline to make a decision.
"It's really life-changing," says Victoria Gray, when describing the gene-editing treatment for sickle cell disease that she received as part of a clinical trial in 2019.to review the scientific evidence for the treatment, including whether sufficient research has been done to assess its long-term safety. The agency has until Dec. 8 to make a decision about the therapy, known as"exa-cel.
The jagged cells cause unpredictable attacks of intense pain and damage vital organs. Throughout their lives, sickle cell patients are repeatedly rushed to the hospital for powerful pain drugs and blood transfusions. They often can't finish school, hold jobs or care for themselves or their families. They're also prone to strokes and other serious complications. Patients usually die about 20 years prematurely.
"I'm worried that this will be a very highly lauded technology that people will not be able to use," says, an assistant professor at the University of Michigan School of Public Health who studies sickle cell."I think the people who need this therapy the most will not be able to afford it."
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