US EditionFDA Approves Leucovorin as Autism Treatment
The FDA will update leucovorin’s label to include treatment for speech deficits in autism, with Medicaid covering the drug for over half of American children, officials said.
- On Monday, the U.S. Food and Drug Administration said it will add an indication for leucovorin to treat speech-related deficits associated with autism during a White House briefing with President Donald Trump and senior health officials.
- Small clinical trials have prompted the review, including a 2018 landmark trial where 48 autistic children showed language gains after 12 weeks and researchers found folate receptor autoantibodies in about 70%.
- Specialists cautioned that evidence remains limited as leading autism research groups and the Autism Science Foundation said studies supporting leucovorin are very small or weak.
- Oz said Monday that Medicaid will cover leucovorin, and private insurers are likely to follow, potentially increasing access for many children covered by Medicaid or CHIP.
- Experts flagged potential supply and regulatory challenges as George Tidmarsh said, `The FDA is collaborating with GSK to broaden the existing Wellcovorin label`, though GSK must submit a drug application.
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PBS NewsHour
BizTocWhat to know about leucovorin, unproven autism drug touted by Trump
When President Donald Trump’s administration announced it would repurpose an old, generic drug as a new treatment for autism, it came as a surprise to many experts — including the physician who suggested the idea to the nation’s top health officials.
Trump is pushing leucovorin as a new treatment for autism. What is it?
MIT Technology Review Explains: Let our writers untangle the complex, messy world of technology to help you understand what’s coming next. You can read more from the series here. At a press conference on Monday, President Trump announced that his administration was taking action to address “the meteoric rise in autism.” He suggested that childhood vaccines and acetaminophen, the active ingredient in Tylenol, are to blame for the increasing preva…
NBC Chicago
Is leucovorin an effective treatment for autism? Here's what research shows
The Trump administration is hailing a medication called leucovorin for reducing some autism symptoms.
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