Leucovorina Shows Promise for Autism, But FDA Approval and Supply Concerns Remain
New York, NY – Emerging research suggests leucovorina, a medication typically used in cancer treatment, may offer benefits for some individuals with autism, prompting discussion about potential new treatment avenues. However, significant hurdles remain before widespread use, including the need for FDA approval and concerns about potential medication shortages.
Studies exploring leucovorina’s affect on autism have involved varying participant numbers, with the largest to date including 80 individuals. Researchers caution that this number is “too small” to produce definitive results,according to Dr. Jeremy Mandell. Securing FDA approval would necessitate trials involving “hundreds of children,” he added.
Leucovorina works by increasing levels of folinic acid, a form of folate, in the body. Some individuals with autism have been found to have lower levels of folinic acid, leading researchers to investigate whether supplementation could alleviate certain symptoms. While initial findings are encouraging,the FDA currently requires GSK,the manufacturer of the brand-name version of leucovorina,to update the medication label and submit a formal submission for the new indication of autism treatment.
GSK stated it is working to fulfill these requirements. Once approved, coverage for leucovorina prescriptions is anticipated from Medicaid, with private insurance companies likely to follow suit, according to Dr.Mehmet oz.
Despite the potential benefits, concerns exist regarding accessibility and quality control. Dr. Mandell warns that planned cuts to Medicaid could force families to purchase folinic acid supplements online, where quality and dosage accuracy are less certain. Furthermore, Dr.william Dahut, scientific director of the American Cancer Society, noted that increased demand for leucovorina due to autism treatment could possibly lead to shortages for cancer patients, as “we have seen shortage of this medicine in the past, and if the interest increases, it is possible that scarcity occurs in the future.”
