FDA Approves Leucovorin for Rare Condition, Not Autism

FDA Approves Generic Leucovorin for Rare Condition, Clarifies Autism Treatment Claims

The Food and Drug Administration (FDA) has approved a generic version of the drug leucovorin for a rare genetic disorder affecting fewer than one in a million Americans. This condition causes neurological issues, including seizures and movement problems.

Earlier claims by President Trump and top officials that the drug could benefit up to 50% of children with autism were later clarified by the FDA. The agency narrowed its review to the strongest data for a specific rare mutation, noting that one key autism study was retracted.

Prescriptions for the drug surged 71% among children aged 5-17 after the initial announcement, leading to shortages and difficulties for families. Major medical groups like the American Academy of Pediatrics emphasize that autism treatment evidence remains weak from small studies.

To address shortages, the FDA is now allowing imports from foreign manufacturers, as the original company has no plans to restart production. Experts stress that autism is a complex condition with no single fix like this drug.

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