The Food and Drug Administration has reapproved GSK’s branded version of leucovorin for the treatment of cerebral folate deficiency, a neurological condition prevalent among children with autism. This decision could significantly impact the dietary supplement market, as parents may seek out products containing leucovorin’s key ingredient, potentially leading to increased sales for supplement manufacturers. However, the approval comes with caveats, as the effectiveness of leucovorin for autism has only been explored in a limited number of small studies.
Research indicates that many children with autism possess an antibody that prevents folate from being effectively transported into the brain, complicating treatment options. Richard Frye, chief scientific officer of the Autism Discovery and Treatment Foundation, emphasizes the need for further investigation into the role of leucovorin in autism management. As the market reacts, stakeholders in the pharma and supplement industries must navigate the implications of this approval while addressing the scientific uncertainties surrounding the treatment.
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