FDA scales back autism hype as leucovorin gains rare-disease approval
TL;DR Summary
FDA officials say there’s insufficient data to approve leucovorin for autism, reversing earlier optimism from RFK Jr. and FDA Commissioner Makary; the drug is now approved for a rare CFD-FOLR1–related cerebral folate deficiency, with off-label autism use left to physician discussion and future research; the initial trial cited in support of autism benefits was retracted, underscoring data limitations.
- FDA backs away from RFK Jr.’s claims about drug’s promise for autism patients Politico
- FDA declines to endorse leucovorin for autism, walking back earlier statements suggesting benefit CNN
- FDA finds little evidence that the generic drug leucovorin can help people with autism PBS
- FDA approves Wellcovorin for ultra-rare disease. The Trump admin touted it as a treatment for autism The Hill
- FDA Approves Drug Trump Touted for Autism to Treat Other Neurological Disorder WSJ
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