(Reuters) -The U.S. Food and Drug Administration announced approval of leucovorin, a form of folic acid that U.S. President Donald Trump was slated to suggest as a treatment for autism symptoms at a White House event on Monday.
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 pediatric 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.
(Reporting by Michael Erman in New Jersey and Ryan Patrick Jones in Toronto; Editing by Caitlin Webber and Cynthia Osterman)
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