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The first commercial gene therapy, Gendicine, was approved in China in 2003, for the treatment of certain cancers. [31] In 2011, Neovasculgen was registered in Russia as the first-in-class gene-therapy drug for treatment of peripheral artery disease, including critical limb ischemia. [32]
However, the therapy exceeded all expectations and at the end of July 2019, Gray was announced as the first patient to be treated for sickle-cell disease using the CRISPR-Cas9 gene-editing technology. [2] Thanks to her gene-edited cells, Gray has been cured of the disease and now lives a symptom-free life. In the trial, over 96% of the eligible ...
[173] [174] In December 2023, the US Food and Drug Administration (FDA) approved the first cell-based gene therapies for treating sickle cell disease, Casgevy and Lyfgenia. Casgevy is the first FDA approved gene therapy to use the CRISPR-Cas9 technology and works by modifying a patient's hematopoietic stem cells. [175]
The US Food and Drug Administration on Friday approved two gene-based treatments for sickle cell disease, including the first therapy that uses the gene-editing technique CRISPR, opening a new era ...
Britain's medicines regulator has authorized the world's first gene therapy treatment for sickle cell disease, in a move that could offer relief to thousands of people with the crippling disease ...
This was an ongoing discussion with no vote or decision about the therapy, but the discussion likely moves the US one step closer to approving a groundbreaking new treatment that uses gene editing.
Exagamglogene autotemcel is the first cell-based gene therapy treatment utilizing CRISPR/Cas9 gene editing technology to be approved by the US Food and Drug Administration (FDA). [13] The most common side effects include low levels of platelets and white blood cells, mouth sores, nausea, musculoskeletal pain, abdominal pain, vomiting, febrile ...
It marked the world's first approval of a CRISPR-based gene-editing treatment -- and it showed that regulators are open to approving these types of products as long as trial data are strong ...