Home / Health / FDA Expands Leucovorin Use, Not for Autism Directly
FDA Expands Leucovorin Use, Not for Autism Directly
10 Mar
Summary
- FDA approval expansion for leucovorin targets a rare genetic condition.
- The drug will not be approved for autism itself, but related symptoms.
- Previously, leucovorin was used to counteract toxic effects of cancer drugs.
The U.S. Food and Drug Administration will announce on Tuesday, March 10, 2026, an expansion of approval for the drug leucovorin. However, this expanded approval is specifically for cerebral folate deficiency, a rare genetic condition that can manifest with symptoms similar to autism. The drug will not be approved for the treatment of autism itself.
FDA officials had explored broadening leucovorin's use for individuals on the autism spectrum. A subsequent systematic review led to a more focused decision on cerebral folate deficiency, where evidence indicated stronger effects. Leucovorin is already approved for counteracting toxic effects from certain cancer drugs, such as methotrexate, which interfere with folate utilization.
