FDA approves drug that Trump due to suggest as autism treatment

FILE PHOTO: Signage is seen outside of FDA headquarters in White Oak, Maryland
FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo
Source: REUTERS

The U.S. Food and Drug Administration announced approval of leucovorin, or folinic 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.

This article was produced by Reuters news agency. It has not been edited by Global South World.

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