Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. Photo: Reuters
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.
