GSK, a biopharmaceutical company, has withdrawn its application to the FDA for leucovorin calcium tablets, months after the White House promoted the drug as a potential treatment for autism-related symptoms, The Wall Street Journal reported April 10.
The FDA approved leucovorin last month to treat cerebral folate deficiency, marking the first FDA-approved treatment for the rare genetic condition. The disorder affects the transport of folate into the brain and can cause developmental delays, movement disorders, seizures and other neurological complications.
The agency did not approve the drug for autism, citing insufficient evidence to support broader use. A senior FDA official said regulators did not have enough data to establish efficacy for autism more broadly.
GSK said it withdrew the application because it does not market the drug and has not sold it since 1999, according to the report. Generic versions remain available and are unaffected by the decision, HHS told the Journal.
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