FDA approves drug that Trump due to suggest as autism treatment
Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, US, Aug 29, 2020.
PHOTO: Reuters file
PUBLISHED ONSeptember 24, 2025 1:37 AM
The US Food and Drug Administration announced approval of leucovorin, or folinic acid, that US President Donald Trump was slated to suggest as a treatment for autism symptoms at a White House event on Monday (Sept 22).
The FDA published a notice in the Federal Register.
GSK previously manufactured leucovorin and sold it under the name Wellcovorin. The company withdrew the drug from the market, but not for reasons of safety or effectiveness.
The Federal Register notice cited "patient-level data on over 40 patients, including both adults and paediatric patients" to support the finding that the drug can improve symptoms from cerebral folate deficiency (CFD).
According to the Federal Register entry, CFD has been reported in patients with neuropsychiatric symptoms, including autistic features.
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