FDA Approves Leucovorin for Autism Symptoms Treatment

The FDA has approved leucovorin, a folic acid form, potentially aiding in treating autism symptoms. Formerly manufactured by GSK as Wellcovorin, it was withdrawn from the market earlier. Studies involving over 40 patients support its efficacy in improving symptoms from cerebral folate deficiency, linked to autistic features.

The United States Food and Drug Administration has given its approval for leucovorin, a form of folic acid proposed by former President Donald Trump as a potential treatment for autism symptoms.

Leucovorin, once sold under the name Wellcovorin by GlaxoSmithKline (GSK), was withdrawn by the company not due to concerns about safety or efficacy, according to an FDA notice in the Federal Register.

That same notice highlights "patient-level data on over 40 patients, including both adults and pediatric patients," demonstrating the drug's potential to enhance symptoms related to cerebral folate deficiency, which has been associated with neuropsychiatric symptoms, including those reminiscent of autism.