The Food and Drug Administration has approved the generic drug leucovorin, but not for autism as previously suggested by the Trump administration. Senior FDA officials stated they found insufficient evidence to support its use for autism.
The agency announced it approved leucovorin for treating cerebral folate deficiency (CFD), a rare genetic condition in adults. This decision contrasts with earlier claims made by administration officials, including former FDA Commissioner Marty Makary, who touted leucovorin as a promising autism treatment based on a supposed "growing body of evidence."
Following the administration's September announcement, outpatient prescriptions of leucovorin for children aged 5 to 17 reportedly increased by 71 percent in the subsequent three months. However, the FDA's official review ultimately narrowed the drug's approved use to CFD, citing a lack of supporting data for its efficacy in treating autism.