WASHINGTON (AP) — The Food and Drug Administration on Tuesday approved a generic medication for a rare brain disorder, while walking back suggestions by President Donald Trump and other administration officials that the drug showed great promise for people with autism.
The agency said it approved leucovorin for children and adults with a genetic condition that limits delivery of folate, an essential form of vitamin B, to the brain. FDA officials estimate the ultrarare condition impacts fewer than 1 in a million people in the U.S.
It’s a major step back from statements made at a White House news conference in September, when Trump and FDA commissioner Marty Makary announced the drug was under review to benefit patients with autism, some of whom have a form of the vitamin brain deficiency.
“It might be 20, 40, 50% of kids with autism,” Makary said at the news conference.