WASHINGTON: The United States Food and Drug Administration has approved leucovorin, a form of folic acid that former President Donald Trump was scheduled to promote as a treatment for autism symptoms.
The FDA made the announcement through a notice published in the Federal Register.
GlaxoSmithKline previously manufactured and sold the drug under the brand name Wellcovorin before withdrawing it from the market for reasons unrelated to safety or effectiveness.
The approval was supported by patient-level data from more than 40 individuals, including both adults and children, demonstrating the drug’s ability to improve symptoms of cerebral folate deficiency.
Cerebral folate deficiency has been documented in patients exhibiting neuropsychiatric symptoms, which can include autistic features. – Reuters