GSK's (GSK) Wellcovorin tablets have been approved by the US Food and Drug Administration for expanded use, the regulator said Tuesday.

Wellcovorin is intended to treat cerebral folate deficiency in adult and pediatric patients with a variant in the folate receptor 1 gene, according to the FDA.

The regulator said its approval was based on a review of published literature on the topic, including case reports with patient-level information, and mechanistic data. According to the FDA, patients with the disorder often have severe developmental delays, movement disorders, seizures, and other neurological complications.

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