Robert F. Kennedy Jr., the United States Secretary of Health and Human Services, earlier claimed that the drug leucovorin could help treat autism. However, two officials from the U.S. Food and Drug Administration have now dismissed the claim. They clarified that the drug is used to treat cerebral folate deficiency in adult and pediatric patients with specific gene variants, not autism.
The comments come after Kennedy and FDA Commissioner Marty Makary revealed plans at a September conference to fast-track the drug’s approval for autism treatment, despite scientists cautioning that there is not enough evidence to support the claim.
FDA reportedly pushes back RFK Jr’s autism drug claims
FDA reportedly backed away from approving the claims made by RFK Jr. and Makary about the leucovorin drug, which they believe could help in treating autism. The Food and Drug Administration released a statement in which Makary said that the drug could be used for cerebral folate transport deficiency, but not autism. “Today’s approval represents a significant milestone for patients living with cerebral folate transport deficiency due to the FOLR1 variant, a rare genetic condition that has had no FDA-approved treatment options until today. This action may benefit some individuals with FOLR1- related cerebral folate transport deficiency who have developmental delays with autistic features,” he elaborated.
This clarification comes amid Makary’s September claims of fast-tracking the approval of leucovorin, which he considered an “exciting” treatment to cure autism among children. At the time, he explained that the condition could be an autoimmune reaction to the folate receptor of the brain, which restricts the required vitamin from reaching the brain cells. He believed that it’s a “mature pathway” to proceed with and feels the necessity to inform doctors and the public.
Moreover, Kennedy Jr. thought that the drug’s approval could surely benefit many children, further sharing a study to support his claims. “One study found that with kids with autism and chronic folate deficiency, two-thirds of kids with autism symptoms had improvement and some marked improvement,” he added. Moreover, the FDA official’s opinion piece in Politico also cleared the air around any doubts about autistic treatment. It clearly stated, “Leucovorin is not a cure for autism but has demonstrated an improvement in speech-related deficits for autism.”
Originally reported by Shazmeen Navrange on Mandatory.
