J&J Seeks FDA Approval for Chewable NTD Drug

Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), has submitted to the US Food and Drug Administration (FDA) a new drug application for a 500-mg chewable tablet formulation of mebendazole. If approved, mebendazole chewable tablets will provide a treatment alternative for adults and children aged one year or older with single or mixed soil-transmitted helminthiasis (STH), and address an unmet need for children too young to swallow a solid tablet.

This submission responds to recommendations by the World Health Organization (WHO) calling for a more child-friendly formulation of mebendazole to effectively treat young children, their families and communities. Specifically, the WHO recommends only chewable deworming tablets be given to children under five years, and that chewable tablets be mixed with water in children under three years.

STH is considered a neglected tropical disease by the WHO. It is a common infection that afflicts approximately two billion peopleworldwide. STH can infect both children and adults, however children are more at risk. Over 270 million preschool-age children and more than 600 million school-age children live in endemic areas and are in need of treatment and preventive interventions.

Source: Johnson & Johnson

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