ARTICLE | Regulation
FDA approves leucovorin sNDA for hundreds, not hundreds of thousands
Approval raises concerns about inconsistent standards, political influence at FDA
March 10, 2026 9:37 PM UTC
FDA has approved an sNDA for GSK’s Wellcovorin for a narrow indication, while stepping back from claims FDA Commissioner Marty Makary made in September that the drug could help “hundreds of thousands of kids” with autism.
The approved indication for the leucovorin calcium tablets is to treat cerebral folate transport deficiency (CFTD) in adult and pediatric patients who have a confirmed variant in the folate receptor 1 (FOLR1) gene...