FDA approves GSK’s Wellcovorin for cerebral folate deficiency

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Source: Pharmaceutical Technology

Original: https://www.pharmaceutical-technology.com/news/fda-approves-gsk-wellcovorin/...

Published: Wed, 11 Mar 2026 09:42:55 +0000

The FDA has approved the expanded use of GSK's Wellcovorin (leucovorin) for the treatment of cerebral folate deficiency (CFD), a rare disorder that occurs in patients with a confirmed variant in the folate receptor 1 gene[1]. It is the first drug approved for this disease, which is characterized by severe developmental delays, movement disorders and seizures[1]. Wellcovorin was originally developed by GSK and was marketed under its brand name between 1983 and 1997[2]. Currently, leucovorin is available in the US as a generic drug[2]. The FDA asked GSK to update the information on the drug packaging based on data from case reports of patients with genetically confirmed CFD[2]. This decision is part of the FDA's initiative aimed at re-evaluating older drugs in order to find new possibilities for their use in the treatment of chronic diseases[2]. GSK has a minimal role in this matter and has no commercial or scientific interest in this indication[6].