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Investing.com -- The U.S. Food and Drug Administration has approved leucovorin, a form of folic acid that President Donald Trump is expected to promote as an autism treatment at a White House event Monday.
The FDA published the approval in the Federal Register, noting that leucovorin can improve symptoms related to cerebral folate deficiency (CFD), a condition reported in patients with neuropsychiatric symptoms, including autistic features.
The drug was previously manufactured by GSK (NYSE:GSK) and marketed as Wellcovorin before the company withdrew it from the market. The FDA clarified that the withdrawal was not due to safety or effectiveness concerns.
The approval is based on patient-level data from more than 40 individuals, including both adults and children, according to the Federal Register notice.
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