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FDA reviewing Casgevy for children with sickle cell as young as 5
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FDA reviewing Casgevy for children with sickle cell as young as 5
The U.S. Food and Drug Administration is reviewing an application from Vertex Pharmaceuticals seeking approval of Casgevy (exagamglogene autotemcel) for children with sickle cell disease (SCD) as young as 5 years old. The gene-editing therapy is currently approved in the U.S. and elsewhere for people ages 12 and older with SCD and recurrent vaso-occlusive crises (VOCs). Vertex’s new application was submitted using a Commissioner’s National Prior…
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