“Currently, as few as 1,500 patients with epilepsy are treated with this medicine globally, with numbers continuing to decline,” the drugmaker told Fox 61 in a statement.
GSK said it has informed regulators of the production decision and is in the process of notifying clinicians. The drugmaker will give healthcare providers about one year to transition patients to alternative treatments before production ceases, according to the report.
A family in New Hartford, N.Y., reached out to GSK, urging the company to keep the drug available through the Food and Drug Administration’s compassionate use program for their one-year-old son with a severe seizure condition who responds poorly to other seizure medications.
GSK told Fox 61 the drug will not be made available through compassionate use terms as the FDA has not approved Potiga for the pediatric population.
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