GSK will submit a supplemental New Drug Application (sNDA) for Wellcovorin (Leucovorin) to update the label to include an indication for the treatment of Cerebral Folate Deficiency (CFD), a rare disorder. The US Food and Drug Administration (FDA) requested GSK take this action as part of the agency’s initiative to investigate opportunities to repurpose older medications for the treatment of chronic diseases.

GSK is supporting this initiative as the NDA holder by adding data from case reports identified by the FDA of genetically confirmed CFD into the US prescribing information for Wellcovorin. The company does not manufacture or market Leucovorin, which is available in generic formulations in the US.

GSK is collaborating with the FDA to request a label update for this medicine as quickly as possible.

In the US, Leucovorin is indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosages of folic acid antagonists. GSK marketed Leucovorin under the brand name Wellcovorin from 1983 to 1997. It is now available in the US as a generic drug.