The Food and Drug Administration on Tuesday approved a drug to treat a rare brain disorder that resembles autism, while pulling back from previous statements made by top health officials that “hundreds of thousands” of children with autism could benefit from taking the drug.
The medication, leucovorin, will be available for children and adults with cerebral folate deficiency, which limits the delivery of folate, a kind of vitamin B, to the brain. The approval was given to GSK, the original manufacturer of Wellcovorin — a branded version of leucovorin — before the company discontinued its production in 1997. The company does not intend to manufacture or market Wellcovorin again.
