FDA Greenlights Leucovorin for Autism-Related Neuropsychiatric Symptoms
The FDA has approved leucovorin, also known as folinic acid, for managing symptoms related to autism. The approval comes amid data on its efficacy for cerebral folate deficiency, associated with autism. Previously marketed as Wellcovorin, it was withdrawn not due to safety issues but business reasons.
The U.S. Food and Drug Administration has given the go-ahead for leucovorin, commercially known as folinic acid, for its potential to treat symptoms associated with autism. This announcement comes ahead of U.S. President Donald Trump's planned endorsement at a White House event on Monday.
According to the FDA's notice in the Federal Register, leucovorin was previously manufactured by GlaxoSmithKline as Wellcovorin, but the company had withdrawn it from the market, citing reasons unrelated to safety or effectiveness. The withdrawal was purely a business decision.
The FDA's approval was based on extensive patient-level data involving over 40 individuals, both adults and children. The data supporter leucovorin's ability to alleviate symptoms linked to cerebral folate deficiency, which is often associated with neuropsychiatric conditions, including autism-related features.
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