(In Sept 22 story, corrects paragraph one to folinic acid from
folic acid)
Sept 22 (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.