GSK Withdraws Application for Leucovorin as Autism Treatment
GlaxoSmithKline (GSK) has withdrawn its application for the drug Wellcovorin (leucovorin) as a potential treatment for autism-related symptoms. This decision follows a request from the FDA to refile the application, citing the drug's potential to treat cerebral folate deficiency (CFD) with autistic features. GSK's withdrawal is procedural, as the drug is no longer marketed, and does not reflect any safety or efficacy concerns. Generic versions of leucovorin remain available, and the withdrawal does not affect their availability or labeling. The FDA's interest in leucovorin was based on its potential to address developmental delays associated with CFD.